Contents

SUBCHAPTER 510 - INSPECTION PROCEDURES

510 - PRE-INSPECTIONAL ACTIVITIES

Prior to the start of any inspection or investigation, you should conduct a number of activities. These will differ based on whether this is an inspection or an investigation. You should a review of the establishment's factory jacket (if one exists), and registration and listing (if applicable) information. The purpose of this review is to determine the location of the establishment and obtain an overview of the establishment's operations and products as well as an understanding of their compliance history. You should also evaluate the establishment factory jacket to determine if there was any prior safety issues noted, e.g. documented Investigator safety incidents or the need for any specific personal protective equipment is needed prior to the start of the inspection. If there has been a past personal safety incident, you should discuss with your supervisor and develop a Situational Plan prior to the start of the inspection. See IOM 510.03 — Situational Plan. Determine if there are any import for export follow-up assignments and be prepared to cover them during your inspection. See IOM 602 for guidance.

Prior to initiating any inspection you should become familiar with the reporting requirements for the specific assignment, as well as the requirements of IOM Sub-Chapter 590.

If the inspection or investigation is a directed assignment from a Center, ORA headquarters or another district, read it and attached materials to assure you understand the assignment. If the inspection or investigation is being conducted in part or solely as a recall follow-up or complaint, refer to Chapter 8 (Recalls) or Chapter 9 (Investigations) of the IOM for additional guidance.

You should review the applicable FACTS assignment to determine if the Personal Safety Alert indicator is checked for this specific firm. The reason for the Personal Safety Alert should be listed in Endorsement and should be accompanied by a Memo to the Establishment File Jacket or documented in a prior EIR. See IOM 510.02 Personal Safety Alert.

You should also review the applicable Compliance Program Guidance Manual(s) prior to the start of your inspection or investigation. ORA's Division of Field Investigations (DFI) has written numerous Inspection Guides to assist you in conducting inspections of various types of establishments, products or processes. You should become familiar with the appropriate guides prior to the start of the inspection and utilize them as needed throughout the inspection. The Centers have issued numerous guidance documents for industry. These documents are normally posted to the appropriate Center's Internet and Intranet web sites. Detailed references are listed by program area in Chapter 10 of the IOM.

Sub-chapters 530-570 of the IOM contain additional, program specific pre-inspectional activities, which you should follow.

Imported products cross all program areas and our regulation of them does not stop at the border. Please be alert to imported products whenever you make an inspection. During inspections of domestic firms, if you encounter counterfeit imported products, returned imported products, rejected imported products or otherwise suspect an imported product should not have been allowed to enter the country, take some time to investigate the source of the imported products. Determine the port of entry and /or the importer if possible. Using the FEI number of the consignee, importer or manufacturer, import personnel can determine the importing pattern of a firm and alert the appropriate ports.

Pre-Announcements - Pre-announcements are mandatory for all medical device inspections in accordance with the criteria and instructions below and BIMO sponsor/monitor inspections. In all other program areas, pre-announcements may be made at the discretion of the district. If you are going to visit facilities where livestock (including poultry) or wild animals are housed or processed, review IOM 519. In general, it may be inappropriate to pre-announce inspections of food establishments, blood banks, source plasma establishments and some BIMO inspections, but this too is subject to district discretion. If a district believes pre-announcing an inspection of an establishment will facilitate the inspection process then the procedures below for doing pre-announcements for medical device inspections should be followed. ORA's primary purpose for pre-announcing is to assure the appropriate records and personnel will be available during the inspection. It is not to make an appointment for the inspection. It should not be referred to as an appointment to inspect. When doing a pre-announcement, it is important you communicate to the establishment the purpose of the inspection and a general idea of the records you may wish to review. If you find neither the appropriate personnel nor records available, note this in your Establishment Inspection Report (EIR). The District may use this data in the future when considering whether this establishment should be eligible for pre-announced inspections.

The following is the general outline for pre-announcement of medical device inspections. You are advising the establishment's management of the date and time you will be arriving at the establishment to conduct the inspection. The establishment has no authority to negotiate this. If you, as the investigator, feel the need to accommodate the establishment's request, be sure there are sound reasons for doing so and report them in your inspection report.

A. Basic Premises

1. Pre-announcement of inspections is to be applied only to establishments that meet specific criteria. Pre-announcement may be considered for establishments that manufacture both drugs and devices or biologics and devices. The eligibility of an individual establishment for pre-announced inspection is at the discretion of the inspecting office using clearly described criteria. (See section B.). The district does not have the discretion to decide the types of medical device establishments eligible for pre-announcement, but may decide the specific establishments' eligibility because they meet the criteria.
2. The pre-announcement should generally be no less than 5 calendar days in advance of the inspection. Should a postponement be necessary, the decision as to rescheduling rests with the investigator/team, but the new inspection date should not be later than 5 calendar days from the original date. Inspections may be conducted sooner than 5 calendar days if requested by or acceptable to the establishment and if this date is acceptable to the investigator/team.
3. To participate in the pre-announcement portion of the program, establishments are expected to meet the commitment to have appropriate records and personnel available during the inspection.
4. Pre-announced inspections will not limit an investigator's authority to conduct the inspection. Inspections will be as thorough as necessary.

When deciding whether an establishment qualifies for a pre-announced inspection, you must consider whether both the type of inspection and the establishment's status meet the following specific criteria.

1. Type of Inspection: Only the following types of inspections are appropriate:
   1. Pre-market inspections (PMA, 510(k)),
   2. Foreign inspections,
   3. Quality System/Good Manufacturing Practice (QS/GMP) inspections:
      * Biennial routine inspections,
      * Initial inspections of new facilities or newly registered establishments, and
      * Initial inspections under new management and/or ownership.
   4. Recall follow-up inspections at manufacturer, initial importer, or U.S. designated agent.
      Other types of inspections do not normally qualify. Inspection types where pre-announcement is not generally appropriate include: Government-Wide Quality Assurance (GWQAP) inspections with short deadlines; immediate and urgent responses to complaints, immediate and urgent follow-up to information from any source, and immediate hazard-to-health, recall follow-up inspections.
2. Eligibility Criteria: Establishment's eligible for pre-notification should meet the following requirements:
   
   1. Non-violative QS/GMP inspection histories (inspections classified as no action indicated (NAI) or voluntary action indicated (VAI)). For VAI, adequate corrections of conditions observed and listed on FDA 483 during the previous inspection were verified and did not lead to any further agency action.
   2. To remain eligible for pre-announced inspections, establishments must have a history of having individuals and/or documents identified in previous pre-announced inspections reasonably available at the time of the inspection.

1. The investigator designated to conduct the inspection will contact the most responsible individual at the facility. You should leave a message requesting a return call if the most responsible person at the facility is unavailable at the time the call is made. The district should use good judgment as to what is a reasonable time frame to await the return call.
2. Changes in dates should be kept to a minimum. If a change is made, a new date should be provided as soon as possible, which will facilitate the inspection and accommodate the investigator's schedule. The establishment should provide a valid reason for requesting a change in the start date. A valid reason should be the same as you would accept if presented with the information during an unannounced inspection.
3. Inform the establishment as to the purpose, estimated duration, and the number of agency personnel expected to take part in the inspection. The products or processes to be covered should be described if this will facilitate and be consistent with the objectives of the inspection.
4. When known, specific records/personnel will be requested at the time the inspection is pre-announced.
5. The notification should be as specific as reasonably possible and specify the date for the start of the inspection.

Include in your EIR whether or not the inspection was pre-announced and include information on any difficulties experienced in notification or accessing records or personnel, which should have been available as a result of pre-announcing the inspection. For medical device establishment inspections, if not pre-announced, describe briefly in the EIR why not. If an establishment should become ineligible for pre-announcement, the endorsement of the EIR should include this statement. This information will be necessary for making a determination regarding future pre-announced inspections of the establishment. In addition, it is advisable to inform the establishment during the current and subsequent inspections of the action(s), which may have caused them to be ineligible for pre-announcement.

Sub-chapters 530-570 of the IOM contain additional, program specific pre-inspectional activities, which you should follow.

510.01 - Personal Safety

ORA considers the safety of Investigators, Inspectors and all those who meet with regulated industry to be of the utmost importance. Personal safety concerns are defined as those factors FDA employees should maintain awareness of which potentially affect their safety during an inspection, such a threatening situation; or where specific personal protective safety equipment is warranted; or where a particular inspection may be medically contraindicated for specific FDA personnel. When these conditions are noted during an inspection, the Investigator should discuss the situation with their Supervisor and ensure that the Personal Safety Alert is marked in FACTS and a Memo to the File is generated— see IOM 510.02 For information concerning personal protective equipment, see IOM Chapter 140

Physical resistance to FDA inspections and threats to, or assaults on, FDA employees engaged in their work are extremely rare. However, there will be times you are confronted by unfriendly or hostile persons. ORA has offered various conflict resolution training courses to assist and prepare you for how to diffuse a situation. In most instances, conducting your activities with tact, honesty, diplomacy, and persuasiveness will be enough to diffuse the situation. While at times, you may have to adopt a firm posture, you should not resort to threats, intimidation, or strong-arm tactics. Refer to IOM 514.01 for Hostile and Uncooperative Interviewees.

Safety is the responsibility of all FDA employees, including you, your supervisor and other Agency management. When you receive an assignment, it is important to evaluate the assignment not only in accordance with IOM Section 510, but also with respect to your personal safety. If you determine there is the possibility of a threat to your personal safety, consult with your supervisor. You and your supervisor should consider developing a Situational Plan in preparation for the inspection.

Below are some suggested items the District may consider when preparing for your next assignment to assess if there are potential personal safety issues. This list is not meant to be all inclusive.

1. Does the assignment involve working with other Federal Agencies such as U.S. Marshals, Federal Bureau of Investigations, US Customs in executing search warrants, seizures etc?
2. Does the assignment involve working with FDA’s Office of Criminal Investigation?
3. Does the assignment involve working in an undercover operation?
4. Does the assignment involve a firm where there is a suspicion and/or knowledge of questionable or illegal activities?
5. Does the assignment involve a suspected tampering and/or a visit to an individual’s residence?
6. What is the past history from a personal safety standpoint with the prior interactions with representatives of this firm? Have the FDA’s State counterparts or other Federal and/or local agencies indicated a concern for personal safety? What does the firm’s establishment file indicate about personal safety over the past inspections?
7. What is the location of the firm or the operation? Is it in an area which may be unsafe? Have the inspected firm or any of it’s employees been uncooperative with government officials?
8. Is the firm known to the Agency? Has the Agency any additional information which would assist in your evaluation?

If these questions and/or others result in a concern for your personal safety, then a Situational Plan should be developed and approved by District management before conducting the assignment. See IOM 510.03 – Situational Plan

Due to the unlimited variability of potential safety situations, it is not feasible to prescribe in the IOM what to do in every instance. The decision of what to do in each individual circumstance rests with the Investigator and their District management. Your district management is most familiar with the specific firm in question, the regulated industry, as well as other local Federal, State and Local officials who may be able to provide you additional information and assistance. In addition, the experience of your District management combined with the various training courses on conflict resolution may also be consulted. Districts should notify Division of Field Investigations to inform headquarters of any potential safety concern, so that DFI may track personal safety issues. DFI will also maintain a library of Situational Plans which may also be of use to your District. DFI may be contacted at (301) 827-5653 or at the following personal safety e-mail address:
ORAHQDFICSOSAFETY@ORA.FDA.GOV

Physical Resistance/Threats/Assaults: If you receive physical resistance or threats, or if you sense the real possibility of an assault, disengage from the confrontation, get to safety, and call your supervisor immediately. Make careful and exact notes later of who said what to whom, who did what, and whether someone tried or succeeded in threatening, assaulting or taking information or equipment or samples from you. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. Your safety is more important to the United States than the inspection or the sample. FDA will work with law enforcement government officials, e.g. FDA's Office of Criminal Investigations' (OCI) Special Agents, local police, or United States Marshals to assist an inspection team if there is a reasonable fear of danger to the investigator.

If you are assaulted (either physically or put in fear by threats of physical violence), your supervisor can summon local police, United States Marshals, FBI or contact OCI headquarters for assistance (301-294-4030). While OCI does not normally provide physical security in these cases, they will assist in threat evaluation based on specific facts and available data bases. OCI can also make contacts with local police and federal agencies based on previous established liaisons. If you have been assaulted or threatened and you are unable to reach your supervisor or other District management, you should contact the local police in the area where the assault or threat occurred. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. Make sure that any inspected facility where weapons are observed, or where threats or assaults occur, is identified on that facility's Endorsement page of the inspection report for that facility and to your supervisor, so that Investigators or Agents who follow you into that facility will be alert to those possibilities. Your supervisor would also be responsible for checking the Personal Safety Alert box in FACTS and for beginning the notification process to alert other Federal or State agencies that also inspect the facility of the possible danger. For more information See IOM 510.02 Personal Safety Alert. For specific safety guidance related to inspections and interviews, see IOM 514.01 Hostile and Uncooperative Interviewees.
In addition, in any instance where you have perceived a threat to your personal safety during an inspection, investigation or sample collection, you should exit the situation immediately and report it to your supervisor. You should then write a memorandum of the event in a factual manner including information pertaining to the who, what, when, where, and how of the event. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. This memo will be filed in the official establishment file jacket and copies be sent to any and all resident posts and import offices who may interact with this firm. The memo will be filed on the opposite side of the folder from all other documents and will be a printed on eye-catching color paper in order for the document to be visible to the next Investigator. The memo should be retained and maintained within the District. A copy of the Memo documenting the personal safety situation should also be sent to Division of Field Investigations, HFC-130.

510.02 - Personal Safety Alert

Within the Maintain Firms Option in the FACTS system, there is Personal Safety Alert option that allows the Supervisor (FACTS Supervisor Role) to check the appropriate box to advise the FDA Investigator that there is a personal safety issue. Only the FACTS Supervisor Role will allow for updating the Maintain Firms screen. This personal safety alert may be selected when there is a potential hazard identified:

• Where specific personal protective equipment is needed (respirators etc)
• Where a previous threat/assault or physical resistance occurred
• Where there are specific medical considerations for a population of Investigators (e.g. the firm manufactures a drug hazardous to women of child-bearing years or those with allergies to peanuts, penicillin, or other products.)

In any example listed where there is a Personal Safety Alert, the specific safety alert should be documented both in the Endorsement and in a Memo to the File. The memo should be flagged “MEMO TO FILE — PERSONAL SAFETY ALERT” and should provide the factual information to support why the Investigator should be alerted to the safety issue. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. The memo should be filed in the official establishment file jacket and copies be sent to any and all Resident Posts and Import Offices who may interact with the firm. The memo will be filed on the opposite side of the folder from all other documents and will be a printed on eye-catching color paper in order for the document to be visible to the next Investigator. The memo should be retained and maintained at the District Office. A copy of the Memo documenting the personal safety situation should also be sent to Division of Field Investigations, HFC-130. The Supervisor and/or other District management will be responsible for evaluating any corrective actions taken by the firm or individual to remove or stop the potentially dangerous situation or condition. If the situation remains potentially dangerous, the Personal Safety Alert should be maintained in FACTS. Follow-up inspections at the facility should continue to document whether or not the safety situation continues exists. If the situation has been resolved (new management, dismissal of an employee, cessation of penicillin in a facility), than the Personal Safety Alert should be removed from FACTS.

510.03 - Situational Plan

A situational plan is an investigative tool developed to assist in managing and preparing for a potentially dangerous situation. Districts should consider developing a Situational Plan when the conditions surrounding the specific inspection, investigation or sample collection indicate a plan is needed. The plan allows all those involved to carefully evaluate the specific inspection in order to prepare for a successful conclusion. Utilizing Situational Planning concepts prior to a potentially dangerous situation is supported by the Federal Law Enforcement Training Center and is part of the training programs of many other Federal Agencies. The plan should document what specific roles and responsibilities are needed to conduct the inspection/investigation or sample collection. The plan should also answer the questions: Who, What, Why, When and Where concerning the potential danger.

There are four principles to a Situational Plan. These are:

• Threat Perception/Assessment: This is the area where the issues are identified and assessed and will assist in the decision making process. It should be noted that the threat perception/assessment must be flexible. In other words, while the threat assessment may identify certain situations, if during the implementation of the plan, other things are identified, these must also be addressed.
• Position of Advantage: Once you have assessed the possible threats in your situation, your plan should include all of the tools that you possess to assist you in handling this situation successfully. For example, what training, experience and other tools do you have at your disposal to assist.
• Response: Once you have identified your position of advantage, the response portion of the plan will identify how you are going to execute the plan. This is where you fill in the specifics of what was listed in the position of advantage.
• Evaluation: This is completed after the plan has been implemented. Were your actions effective? Are other actions necessary? Is the situation under control? Is the inspection team safe? What are the next steps? This evaluation or debriefing should include all of the team members in order to fully evaluate the situation. There should be a debriefing with all involved, including District management to discuss how the plan worked and where the plan may need improvement in the future.

The situational plan should be developed by the Investigator, Supervisor, other CSO’s who may be familiar with the facility, Compliance Officer, if needed, and any other individuals (District experts etc.) who may be able to assist in the depth, scope, and specifics of the firm in question. The decision of who should be involved in the development and approval of the plan is left to the Districts’ discretion.

District management and all involved in writing the Situational Plan should meet when necessary in order to assure a well developed, and understood Situational Plan. You and your supervisor should maintain contact during the execution of the Situational Plan. The Supervisor should contact the employee during these personal safety situations at a predetermined frequency outlined in your plan. A debriefing session should be held following the execution of the Situational Plan. This debriefing session should be held with all those who were involved in the development and execution of the plan. Discussions should include what actions worked well and where there are areas of improvement.

For foreign inspections where a situational plan is warranted, DFI will assist the inspection team. The inspection team’s management may also wish to participate so that there is a clear understanding of what actions will be taken for the foreign inspection.

A copy of completed and executed Situational Plans must be sent to DFI (HFC-130) in order for DFI to maintain a reference library of all situational plans.

See Exhibit 510-D of this section, an example of questions that an Investigator and/or Supervisor may wish to consider when establishing a situational plan.

511 - NOTICE OF INSPECTION

Upon arrival at the firm locate the owner, operator or agent in charge of the establishment. This should be the top Management Official on site. Be certain of this individual's status. Introduce yourself by name, title and organization. Show your credentials to this person and present a properly signed, completed, original of the FDA 482, Notice of Inspection, including the attachment page "Resources for FDA Regulated Businesses". This attachment provides information for the firm in the event it has disagreements or complaints. See IOM Exhibit 510-A1.

If additional Agency personnel accompany you during the inspection, they must show their credentials to the top Management Official upon arrival at the site. A new FDA 482, Notice of Inspection must be issued. Submit the carbon copy of the FDA 482(s) with your EIR. Explain the purpose of your visit. Readily accept any management offer to have a representative accompany you on the inspection.

For multiple occupancy inspections in drug establishments, refer to IOM 501.04. Inspections of multiple firms, which are separate legal entities, should be reported under separate EIRs.

If faced with a refusal, or partial refusal of inspection proceed as outlined in IOM 514.

Any time a FDA 482 is issued, also issue FDA 484, Receipt for Samples, if you collect any samples at the firm. See IOM 513. See IOM 401.01 & 401.02 for instructions for issuance of the FDA 482 in certain sampling situations.

See IOM 401.01 for issuance of a FDA 482 for sample collections only. The FDA 482 may be amended "To Collect Samples Only" as shown in IOM Exhibit 510-A2.

If you have concerns of when to or when not to issue the FDA 482, discuss with your supervisor.

511.01 - Multiple Date Inspections

If your inspection covers more than one day, advise management at the close of each day you have not finished the inspection and when you will return. Do this each day until you finish the inspection. A FDA 482 is not required for each day of an inspection or when different individuals are interviewed. If there will be an extended period of time (i.e., a week or longer) before you can return to the firm to complete the inspection, be sure management is aware of the delay and discuss with your supervisor whether or not you need to issue another FDA 482.

511.02 - Inspection of Vehicles

If vehicles are present which are owned or leased by the firm being inspected and it is necessary to inspect the vehicles, the inspection of these is covered by the FDA 482, Notice of Inspection, you issued to the firm.

If vehicles (trucks, trailers, RR cars, etc.) which are not owned or leased by the firm are present and inspection is necessary, a separate FDA 482, Notice of Inspection, is required:

1. Issue the FDA 482 to the driver of the vehicle.
2. If the driver is not present and if, after a diligent search, he cannot be located, issue a separate FDA 482 jointly to the firm being inspected and to the firm whose name appears on the cab. Enter the license number of the vehicle on the FDA 482. Give the original FDA 482 to the firm and leave a copy in the cab of the vehicle.
3. If there is no cab present, prepare a separate FDA 482 modified to read "*** to inspect unattended vehicle ***" and issue it to the firm being inspected as the "agent in charge" of the vehicle. Enter the license number of the vehicle, trailer or RR car number, etc., on the FDA 482. Should the firm being inspected refuse to accept the Notice, leave it in a conspicuous place in the vehicle. Describe the circumstances in your EIR.

511.03 - Follow-Up Inspections by Court Order

When assigned to conduct inspections under these situations, obtain a copy of the injunction or other court order bearing the filing stamp and all relevant signatures. Prior to starting the inspection study the order thoroughly for any special instructions of the court. Your supervisor will assist you in determining the depth of the inspection necessary to cover all of the court requirements.

Take a clearly legible copy of the court decree (not necessarily a certified copy) with you to the firm to be inspected.

Present your credentials in the same manner as for any other EI. Issue the FDA 482, Notice of Inspection, modified to read, "Notice of Inspection is hereby given under authority of injunction (provide here the injunction number and/or other identification) against the firm and pursuant to Section 704 ***". Show the person to whom the FDA 482 was issued a copy of the Order, and, read the following statement to that person.

"This inspection is being conducted under the authority of injunction (add the injunction number and/or other identification) (or other court order) granted by the United States District Court against this firm on (date). The inspection will cover all items specified in the decree. In addition to the inspection authority granted in the court decree, I am issuing you a Notice of Inspection under the authority of Section 704 of the Federal Food, Drug and Cosmetic Act which authorizes inspections of firms subject to that Act."

If, the firm refuses access to records, facilities, or information for which the decree provides inspectional authority, read the pertinent section(s) or portion of the order to the person refusing so there will be no misunderstanding as to the requirements of the decree. If the person still refuses, report the facts to your supervisor as soon as possible so the court can be promptly advised of the situation. See IOM 514 for information on handling refusals.

At the conclusion of the inspection and a FDA 483 is to be issued and you are using Turbo EIR, follow the Turbo instructions to get injunction specific cites on the FDA 483.

When you prepare your EIR, describe the sequence of events in detail including exactly what happened and how you handled the situation. This documentation will help support any charge of violating the court order and/or Section 704 of the FD&C Act [21 U.S.C. 374].

The court order may require a report to the court. Discuss this with your supervisor since the district will normally handle this part of the requirement.

511.04 - Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action

You should not issue a Notice of Inspection if the agency is contemplating taking, or is taking, criminal action against a firm without first discussing the matter with your Supervisory Investigator. Federal Rules of Evidence may not permit using evidence in a criminal matter if it is knowingly obtained under administrative authorities such as Section 704 of the FD&C Act [21 U.S.C. 374]. It is the responsibility of the office generating the inspection assignment to inform the District if a criminal action is ongoing or contemplated. Once alerted, the Supervisory Investigator will then obtain advice from the Office of Chief Counsel and, once obtained, will assign the inspection to the Investigator(s).

Decisions to inspect under such circumstances should be based on considerations of whether or not the request is consistent with FDA's responsibility to assure articles are not produced or distributed in violation of the Federal Food, Drug, and Cosmetic Act or other Federal law within FDA's jurisdiction. It would be lawful to conduct an inspection to identify such violative products and to determine if corrective action was necessary to bring such products into compliance. However, it would be an abuse of the regulatory inspection authority for FDA to conduct a regulatory inspection under that authority for the sole purpose of gathering evidence of criminal violations. Such an abuse is unlawful, and could have significant consequences.

This is because, in general, the Fourth Amendment to the United States Constitution prohibits searches without a warrant. One exception to the warrant requirement includes the inspection of industries long subject to close supervision and inspection, which are conducted under a statute that dispenses with the need for a warrant. Because such inspections are not subject to advance scrutiny for probable cause, as would be an inspection conducted pursuant to a criminal warrant, the Supreme Court has warned government entities not to use administrative inspections to search for criminal violations in an effort to sidestep the Fourth Amendment. So long as the Agency conducts the administrative inspection in good faith for a valid, non-criminal purpose, evidence gathered in such inspections generally may be used in a criminal prosecution. However, the facts of each case are unique, and employees involved must carefully document the Agency's purpose in conducting the inspection.

Because the Agency's underlying purpose in conducting an inspection ultimately will determine whether the inspection was conducted in good faith to pursue a valid, non-criminal purpose it is important to document the non-criminal purpose for an inspection undertaken under these circumstances. The need for and extent of such documentation is at a minimum when the non-criminal purpose of the inspection is evident and compelling, for example, when the purpose is to determine articles are being produced in conformity with the Food, Drug, and Cosmetic Act. The need to document the non-criminal purpose of the regulatory inspection increases as the likelihood of criminal prosecution increases. For example, there would be an increased need to document the regulatory purpose of an inspection if the matter has been referred to the Department of Justice for grand jury investigation.

There may be occasions when neither the office generating the inspection assignment nor the District conducting the inspection is aware the Office of Criminal Investigations is conducting a criminal investigation of a firm that is the subject of a regulatory inspection. The Office of Criminal Investigations may determine it is not in the interest of the agency to disclose to other components of FDA the existence of its investigation, as long as the Office of Criminal Investigations is not involved in the agency decision to conduct a regulatory inspection. However, the Office of Criminal Investigations and other components of FDA may also share information as set out below.

511.05 - When Evidence of a Criminal Violation is Discovered in the Course of a Regulatory Inspection

There may also be occasions where you are conducting a regulatory inspection at a facility, and, in the course of that inspection, you discover evidence of a criminal violation. If this occurs, you should continue the regulatory inspection as you would under normal circumstances. Document the observation and notify your supervisor. Evidence of the observation could be used in a criminal investigation, and the evidence could legally be disclosed to criminal investigators.

If you know criminal investigators are conducting a criminal investigation, your supervisor should notify the criminal investigators of any such observations. If you do not know of any ongoing criminal investigation, your supervisor should refer the information for review by the Office of Criminal Investigations. See the current Regulatory Procedures Manual (RPM). If the regulatory inspection is Center-directed (such as a bio-research monitoring inspection, a pre-approval inspection, or an inspection related to data integrity issues) your supervisor should immediately notify the Center involved of the referral to the Office of Criminal Investigations.

The discovery of evidence of a criminal violation may also be relevant to FDA's responsibility to assure articles are being produced in conformity with the Food, Drug, and Cosmetic Act. Additional inspections may be warranted. Such inspections should be planned and documented in accordance with the preceding section, "Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action."

511.06 - Use of Evidence Gathered in the Course of a Criminal Investigation

The extent to which information gathered in the course of a criminal investigation may be shared with other components of FDA will vary with each case. Investigators should determine the extent of information sharing in accordance with the following guidelines.

Information and evidence gathered in the course of a criminal investigation may be shared with regulatory personnel, subject to two reservations:

1. Information obtained pursuant to grand jury subpoena or testimony may not be shared. Disclosure of such information to anyone other than individuals identified by the Department of Justice attorney involved could subject the individual making the improper disclosure to sanctions for contempt by the court. Only the court can authorize disclosure beyond these parameters. Information obtained by other means (search warrant, cooperative witnesses, surveillance, etc.) may be shared, subject to the following paragraph.
2. There may be a need to protect the confidentiality of the criminal investigation. For example, disclosure to regulatory investigators might prematurely disclose the existence of the criminal investigation or the identity of confidential informants. However, whenever you are calculating the need to protect the confidentiality of information gathered in the course of a criminal investigation through means other than the grand jury, you must consider whether it will be in the interest of public health to protect the confidentiality of that information.

Criminal investigators should consult their supervisors to determine whether disclosure should be made to regulatory investigators.

511.07 - Use of Evidence Voluntarily Provided to the Agency

Criminal and regulatory investigators may share information and evidence voluntarily provided to FDA, without use of the regulatory inspection authority, search warrant, or subpoena. If criminal investigators decide not to share such information because of a need to protect the confidentiality of the criminal investigation, they should consider the potential impact on the public health of protecting the confidentiality of that information.

511.08 - Concurrent Administrative, Civil, and Criminal Actions

It may be appropriate to seek administrative and/or civil remedies against a firm or individual under investigation for criminal violations. There are many issues involved in determining whether such actions may proceed concurrently, or whether certain actions should proceed first. Each situation must be evaluated on an individual basis. If administrative and/or civil remedies are under consideration against a firm or individual also under investigation for criminal violations, representatives from the Center responsible for evaluating the administrative and/or regulatory action should meet with the Office of Criminal Investigations Headquarters staff to issues related to the timing of administrative, civil, and criminal actions. The Office of Criminal Investigations and other components of FDA may share information subject to the reservations set out earlier.

511.09 - Working with a Grand Jury

Finally, if you are assigned to work with a grand jury, you should not participate in a regulatory inspection or other regulatory matter involving the same firm or individual(s). Such participation is contrary to long standing agency policy, might be unlawful, and could result in sanctions against the investigator and the agency. You should not participate in any regulatory matters that could result in improper disclosure of grand jury information, even after the grand jury investigation is closed. Grand jury proceedings remain secret even after they are concluded. Under no circumstances should you undertake such participation without first obtaining clearance from the Department of Justice attorney or the Office of Chief Counsel attorney assigned to the grand jury case. See IOM 705 for additional information on Grand Jury proceedings.