Contents

SUBCHAPTER 590 - REPORTING

590 - ESTABLISHMENT INSPECTION REPORT (EIR)

See IOM 100 English language requirement. The EIR consists of the following in this order: a printed copy of the FACTS Establishment Inspection Record (EI Record) including, at least, the endorsement with the EIR distribution printed at the bottom of the "endorsement" section of the EI Record; carbon or other copies of FDA forms issued during the inspection such as the FDA 482, FDA 483, and FDA 484; investigator's narrative report; copy of assignment if available; exhibits; and/or any additional material attached and referred to in the narrative report. Regarding the use of checklists (such as the BSE Checklist), the original raw data completed checklist should be submitted with the EIR. If you maintain the data in your diary, rather than entering directly on the form, then enter on the electronic copy. A printed copy from FACTS becomes the data to include with the EIR.

No copies of inspection reports will be maintained other than in headquarters, district, and resident post files. The signed original report is maintained in the district office or in the case of foreign inspections in the appropriate Center HQ office.

591 - ENDORSEMENT

The endorsement of the establishment inspection is prepared by the supervisor. Some supervisors may have the investigator prepare proposed endorsements. Endorsements should fit in the available space provided in FACTS. If the endorsement exceeds the 2000 character space provided in FACTS, a separate endorsement should be prepared, fully identifying the firm with a Summary of the Endorsement included in FACTS. The FACTS EI Record will be printed and used as the endorsement and routing document to accompany the EIR. See also IOM 593.01.

Normally the endorsement consists of:

1. The reason for the EI, i.e., workplan, or assignments from headquarters. State the subject of the assignment and reference. If the assignment was issued hard copy (i.e. not through FACTS), it should be attached to the EIR following the narrative. Include the FACTS assignment number and compliance tracking number if applicable.
2. A brief history of previous findings including classification of previous EI, any action taken by the district and/or corrective action taken by the firm in response to inspectional observations from the previous inspection.
3. A concise summary and evaluation of current findings and samples collected.
4. Refusals, voluntary corrections or promises made by the firm's management.
5. Classification and follow-up consistent with inspectional findings and Agency policy including notification of other districts and headquarters as warranted.
6. Distribution consistent with District policy and the requirements of the specific Compliance Program Guidance Manual(s).

The Compliance Status Information System (COMSTAT) was a separate Agency database summarizing Quality Systems regulation (QS/GMP) and current Good Manufacturing Practices (cGMP) regulations for facilities, which manipulate drug, device, and biological products. QS or GMP status of firms inspected is now entered into the FACTS database. The Profile Data is submitted electronically to the Division of Compliance Information and Quality Assurance (DCIQA), HFC-240, following an inspection. DCIQA should be notified via hardcopy, e-mail or FAX as soon as an inspection reveals a violative QS or GMP situation, which may result in regulatory action. Often this may occur before the inspection has concluded.

See Exhibit 590-C. The COMSTAT Guidance to Field and Centers document replaced Chapter 15 of the GWQAP Manual and can be accessed from the DCIQA web site at http://web.ora.fda.gov.

591.01 - Compliance Achievement Reporting System (CARS)

FACTS is used to report achieved and verified compliance actions, which are not the result of a legal action. A compliance achievement is the observed repair, modification, or adjustment of a violative condition, or the repair, modification, adjustment, relabeling, or destruction of a violative product when either the product or condition does not comply with the Acts enforced by the FDA. There are three criteria for reporting into the CARS system:

1. The detection or identification of the problem. A problem may be observed by FDA, other federal officials, or by state or local authorities and referred to FDA; and as a result of an inspection, investigation, sample analysis, or detention accomplished by ORA or states under contract to ORA.
2. The correction of the problem. The correction is directly attributable to the efforts of ORA or state officials under contract to ORA (involving contract products only); and is unrelated to the filing of a legal action, i.e., seizure, prosecution, injunction.
3. The verification of the correction of the problem. The correction is verified by the FDA, other federal officials or state or local authorities and reported in writing to the FDA; and is based on an inspection, investigation, sample analysis, or letter from a firm to FDA certifying the problem has been corrected.

Only when the corrective action(s) has been verified should a CARS be reported. The data elements are those entered/coded in FACTS (See IOM Exhibit 590-B):

1. PAC. See the Data Codes Manual. Should there be insufficient space to code all corrections verified on an occasion, record the most significant corrections.
2. PROBLEM TYPE. The problem type is the problem(s) identified during the operation(s). Use the List of Values (LOV) found in this field on the Compliance Achievement Reporting Screen. If 'Other' is chosen, you must include an explanation in the 'Remarks" field.
3. CORRECTIVE ACTION. The action the establishment took to correct the identified problem. Use the LOVs found in this field on the CARS screen. If "Other" is selected, you must include an explanation in the "Remarks" field.
4. VERIFICATION DATE. Use the date the corrective action(s) is verified, either through an establishment inspection, an investigation, or a letter from the establishment certifying the corrections have been made. Include documentation to verify the action such as repair receipts/plans.
5. CORRECTING ORGANIZATION. The FDA, other federal agency, or state or local authority, which observed the verified correction. Use the LOVs found in this field on the CARS screen.
6. REPORTING DISTRICT. The FDA, other federal agency, or state or local authority, which is actually inputting the verified correction. Use the LOVs found in this field on the CARS screen.
7. REASON FOR CORRECTION. The action the FDA took to make the correction happen. Use the LOVs found in this field on the CARS screen. If 'Other' is chosen, you must include an explanation in the 'Remarks' field.

592 - FACTS ESTABLISHMENT INSPECTION RECORD (EI Record)

Instructions for completion of the FACTS (Field Activities and Compliance Tracking System) EI Record will be included in future revisions. Until such time consult with your supervisor and District Lead FACTS user(s). See IOM Exhibits 590-A & 590-B. The FACTS Profile Data instructions and FACTS generated assignment are attached as IOM Exhibits 590-C & 590-D.

Inspectional accountable time in FACTS consists of the hours devoted to file reviews (operational preparation), actual inspectional, investigational, audit, etc. time (onsite), document (exhibit) preparation and EIR (report) write-up. Accountable time does not include travel time. One occasional exception could be when more than one participant in an inspection/investigation travel together and discuss/prepare while in route. Other accountable time operations are listed in the FDA Data Codes Manual.

593 - NARRATIVE REPORT

See IOM 100 English language requirement. The narrative report is the written portion of the EIR, which accurately describes the investigator's inspectional findings. The narrative report may be prepared in two formats depending on the type of inspection, inspection classification, and program area. A Summary of Findings narrative report is used for non-violative, non-initial inspections - see IOM 593.01. The Standard narrative report is used for human pharmaceutical and medical device inspections, and Official Action Indicated (OAI) classified inspections in other program areas - see IOM 593.03. The "Summary of Findings" report format may be used for some Voluntary Action Indicated (VAI) classified inspections as directed by your supervisor. Additional requirements for human drug and medical device reports are described in IOM 549 and 559. For all reporting formats, include additional information as directed by your assignment, Compliance Program Guidance Manual, or your Supervisor.

All reports must be prepared as stand-alone documents outside of FACTS. Your Establishment Inspection Report (EIR) must:

1. Be factual, objective, and free of unsupportable conclusions.
2. Be concise while covering the necessary aspects of the inspection.
3. Not include opinions about administrative or regulatory follow-up.
4. Be written in the first person.
5. Be signed by all FDA and commissioned personnel participating in the inspection. See IOM section 502.04 when more than one FDA or commissioned person participated in the inspection.

593.01 - Non-Violative Establishments

Investigators should use "Summary of Findings", stand-alone, narrative reports for non-violative establishments, unless otherwise directed by your supervisor, the assignment or the Compliance Program Guidance Manual involved. Exception: human pharmaceutical and medical device GMP inspection reports, which have additional reporting requirements should be written in the Standard Narrative report format as in 593.03. The Summary of Findings Report may not be written solely in the FACTS provided "Inspection Summary" heading. The Summary of Findings report must include:

1. The reason for the inspection;
2. The date, classification and findings of the previous inspection;
3. The actual inclusive dates of the inspection (these may be included as part of a header or in the body of the EIR.)
4. The name of the person to whom credentials were shown and the Notice of Inspection was issued and the person's authority to receive the Notice. Explain if you were unable to show credentials or issue forms to top management;
5. The scope of the inspection; i.e., comprehensive or directed; and a brief description of the products, processes or systems covered during the inspection; the manufacturing codes and if necessary their interpretation.
6. The significant findings if any;
7. Management's response or corrections;
8. Warnings given to management; and
9. The investigator's handwritten signature.

593.02 - Violative Establishments

1. the objectionable conditions or practices described in sufficient detail so someone reading the report will clearly understand the observation(s) and significance.
2. the objectionable conditions or practices cross-referenced to FDA 483 citations, samples collected, photographs, or other documentation including exhibits attached to the EIR.
3. information as to when the objectionable conditions or practices occurred, why they occurred, and who is or was responsible, developed to the highest level in the firm.

593.03 - Individual Narrative Headings

There are many acceptable ways of organizing a narrative report. The key is to cover the required information in IOM 593and 593.02, or as required by the assignment, Compliance Program Guidance Manual, or your supervisor.

The appropriate use of headings should not result in repetition of the same information in different sections. You are encouraged to create headings as necessary to present the inspectional findings in the most concise manner.

For non-violative and some VAI reports, a single heading such as "Summary of Findings" is sufficient (for exceptions, see IOM 593.01)

Turbo EIR must be used to generate the FDA 483 and write the EIR for any inspection where all applicable cite modules exist. You cannot write the EIR in Turbo if the FDA 483 was issued to the firm and it was NOT generated using Turbo EIR. NOTE: Turbo EIR can be used to write the EIR for any inspection where no FDA 483 was issued.  

STANDARD NARRATIVE REPORT: HEADINGS, CONTENT AND ARRANGEMENT OF YOUR REPORT

The Standard narrative report format is the format used for most reports in all program areas. The Standard narrative format contains sections within specific headings. Reporting requirements under these headings fall into two categories: those which must be reported every time (if applicable) and those which only need to be reported if an element has changed (example: Jurisdiction - "changes in the current catalog of products"). You should follow the Standard narrative reporting guidance for specific program areas in the situations below noting any exceptions or additional information which may be required.  

Initial or OAI classified inspections: A full standard narrative report is required for all program areas.

Note : All human drug inspections require full narrative reporting regardless of classification.While a complete Standard Narrative is required, this format does not require full and detailed narratives for every area/element for every human drug inspection. The firm's state of compliance, the previous inspectional report and information, complexity of operations and other aspects all are determinants in how much reporting will be necessary. In many cases, brief summaries addressing the format areas will be sufficient.

Other additional reporting for human drug and medical device inspections may be required - see IOM 549 and 559.  

Reporting of "changes only" is permitted for:

Non-initial, NAI classified inspections - Medical Device inspections

Non-initial, VAI classified inspections - Biologics, Bioresearch Monitoring, BSE, Cosmetics, Food, Medical Device, Medicated Feeds, and Veterinary Drug inspections

HEADINGS:

Summary

1. provide the reason for the inspection (e.g., compliance program, by assignment, etc.);
2. the scope of the inspection (comprehensive, directed, sample collection only, etc.).
3. Provide a summary of the findings, date, and classification of the previous inspection and the firm ’s response/corrective actions.
4. List the products, systems and processes covered during the current inspection, and the types of records and documents reviewed.
5. Provide a summary of the current findings, refusals, samples collected, warnings given to management, and a summary of management's response or voluntary corrections.

Persons Interviewed and Administrative Data

1. The firm name, address, phone, FAX and e-mail address.
2. Report the names and titles of the Investigator(s), Analyst(s), etc.
3. The inclusive date(s) of the current inspection, i.e., list the actual dates in the plant.
4. Report changes to hours of operation (include seasonal variations).
5. If a team inspection and some individuals were not present during the entire inspection, indicate dates in plant for each team member.

Report Full Names and Titles of:

1. to whom Federal credentials were shown,
2. to whom any FDA forms were issued to or signed by during the inspection (FDA 482, 483, 484, 463, etc.),
3. who wrote which section of the EIR, if this was a team inspection report, and
4. in-plant inspectors or other government agencies (IOM 538)

History

1. Report the legal status of the firm (corporation, partnership, limited liability corporation, etc.); If a corporation, list in which state and when the firm was incorporated.
2. List the parent corporation, corporate address and any subsidiaries.
3. Provide a summary of any regulatory actions and prior warnings (do not cite any action only recommended but not approved).
4. Include any relevant recalls, etc. since the last inspection.
5. Report the hours of operation and any changes from past inspections (include seasonal variations).
6. Report the current registration(s) status or any changes to registration status.
7. If directions to the firm would be helpful in future visits, include the information.
8. Provide the names, titles and addresses of top management official(s) to whom correspondence should be addressed (FMD 145, PIN letter, W/L, etc.).

Interstate (I.S.) Commerce

1. Report changes in the previous estimate of the percentage of products shipped outside of the state (or exported to the U.S.) and the basis of the estimate.
2. Report the firm's general promotion and distribution patterns.
3. If there is a violative product, provide examples of I.S. shipments of violative product(s); or
4. if no such shipments, I.S. shipments of major components of violative products - with complete I.S. documentation in either case.

Jurisdiction (Products Manufactured and/or Distributed)

1. Include changes in the current catalog of products, or a list of a representative number of currently marketed products subject to FD&C Act or other statute enforced by FDA or counterpart state agency, including any believed violative.
2. Report changes of Brand Names used.
3. Collect appropriate labeling (product and case labels, inserts, brochures, manuals, promotional materials of any type) for those products believed violative or representing any significant new or unusual operation, industry or technology; or as directed by your supervisor.
4. Document any applicable labeling agreements (and obtain a copy) and statutory guaranty given or received per Sections 301(h) and 303(c)(2) of the FD&C Act [21 U.S.C. 321 (h) and 333 (c)(2)] (IOM 526)

Individual Responsibility - Report with whom you dealt, and in what regard (both during and prior to the start of the inspection):

1. who provided relevant information,

2. who accompanied you during the inspection,

3. who refused access to required records or any other refusal of information (Note: a separate heading for Refusals may be needed if refusals are significant, extensive or an Inspection Warrant is anticipated),

4. who refused to permit inspection (IOM 514) and

5. who participated in the discussion with management (IOM 516)

Describe roles and authorities of responsible individuals, including the full names and titles of individuals providing you with information.

Report changes to the following:

1. Who is the most responsible individual at the inspected firm? Who is the responsible head or designated correspondent? Refer to IOM 525, 525.01, and 525.02
2. Report full names and titles of owners, partners, and corporate officers. Who has the duty, power and responsibility, and authority to prevent, detect, and correct violation(s), and how is this demonstrated and/or documented? See IOM 525.02
3. Report the chain of command; include an organizational chart (create if necessary).
4. Obtain a copy of public annual report, if any.
5. List the names and titles of key operating personnel.

Firm's Training Program - The firm's training programs are of particular significance where inspectional findings find people may not be adequately trained.

Manufacturing/Design Operations

1. Report only changes to the firm's general overall operations, including significant changes in equipment, processes, or products since the previous inspection. Include schematics, flow plans, photographs, formulations and diagrams, if useful.
2. List names and sources of new or unusual components or raw materials.
3. Report equipment considered new or unusual unless otherwise directed.
4. Submit pertinent formulas (especially those being manufactured during your inspection) and processing instructions with labeling of suspect products.

For human drug inspections:

1. Describe the firm's manufacturing processes, systems and operations relevant to your inspection.
2. Summarize the processes covered during the inspection.

The use of layouts, flow plans, schematics, etc. attached as Exhibits to your report is encouraged. A detailed description of operations may be necessary when related to deviations from GMP(s) or application commitments, or when significant changes in the manufacturing operations have occurred.

Additional information for medical device inspections :

1. For all inspections covering CAPA - indicate which data sources were available for review and which were actually reviewed;
2. include a brief statement regarding coverage or non-coverage of applicable Tracking requirements, MDRs, sterilization, and Reports of Corrections and Removals.
3. For ALL Level 2,3, and For Cause Inspections: for Production & Process Controls - indicate which production processes were covered/reviewed.
4. Under the Design Control system, indicate the design project(s) covered during the inspection.

Manufacturing Codes

1. If the manufacturing codes are unchanged, include a statement in the EIR the system is the same as described in reports on file at the District. Indicate the date of the EIR in which the codes are fully explained.
2. If the manufacturing codes have changed, describe the manufacturing coding system (lot, batch, product, etc.), and a key to interpretation of codes.

Complaints (if applicable) - Note: The complaints included in this portion of the EIR are those reported to the FDA by consumers, health care professionals, industry, etc. - Not necessarily the complaints received by the firm.

1. Describe injuries or other significant consumer/trade complaints, DPPR's, MDR's, MedWatch reports, or recalls, if appropriate.
2. Report your follow-up of consumer/trade complaints, DPPR's, MDR's, MedWatch reports or recalls identified in the district factory jacket for coverage. Correlate consumer/trade complaints, DPPR's, MDR's, MedWatch reports to specific objectionable conditions observed.
3. The reporting of your review of the firm's complaint file(s) should be reported under a separate section, such as "Complaint File(s)."
4. In addition, if Returned Goods are examined, describe findings. If not examined, so indicate.

Recall Procedures - Describe plans and procedures for removing products from marketing channels if necessary.

Objectionable Conditions and Management's Response (those written and provided to management at the conclusion of the inspection)

1. If any observations were provided to management in writing (FDA 483) at the conclusion of the inspection list each observation.
2. Provide a detailed discussion of each observation and its relevance, i.e., present and explain your documentation/evidence.
3. Cross-reference each observation to your exhibit(s) and sample(s) collected.
4. Identify the responsible party for each violation.
5. Identify which team member (if applicable) was responsible for the observation.
6. Report management's response to each item and time frames given for corrections and/or any corrective action taken for each observation.
7. Report any disagreements with or refusals to correct any observation(s).

For human drug inspections :

PDMA Coverage

1. Describe what sample loss, theft, or diversion reports were covered during the inspection.
2. Describe the firm's sample audit and security systems, including a review of the firm's SOP's. Significant problems which may contribute to the firm's inability to adequately monitor sample distribution via sales representative, mail or common carrier should be addressed under objectionable conditions.

Additional information for medical device inspections :

1. for each observation based on sampling of records, indicate which Sample Table and level of confidence was used and the actual number of records sampled.
2. If the number sampled is different than the actual number reviewed, so indicate.

NOTE: Observations of a verbal nature should be reported in sufficient detail under the General Discussion with Management (correlate any Exhibits, samples, etc. to any "verbal" observations).

Refusals - Provide full details of all refusals of/for requested information, statutory information, photography, entry, etc. received during the inspection, including who made the refusal and, if available, why the refusal was given.

General Discussion with Management

1. Report the names and titles of all present, including those present via electronic media (describe).
2. Include the name and title to whom the FDA 483 was issued.
3. Provide additional discussion items not provided in writing at the conclusion of the inspection, such as: questionable labels, labeling and/or labeling practices, commercialization of products covered by IDE or IND, fraudulent health claims, registration/listing deviations, lack of approved PMA, 510(k), NDA, ANDA, etc. These include all verbal observations deemed not to merit inclusion on the FDA 483 (IOM 512)
4. A description of each warning, recommendation, or suggestion given to the firm, and to whom given.
5. Management's general responses to the inspection and/or to groups of items listed on the report of observations or discussed at the conclusion of the inspection.

Additional Information - Report changes only.

1. Describe contractors used and for what purpose.
2. Describe suppliers (major raw material, active ingredient, etc.) used and for what.
3. Report pertinent facts, which do not fit another section of the EIR. (For firms located in foreign countries, include information relative to lodging and travel; for domestic firms, include information relative to location of firm if difficult to find; etc.).

Voluntary Corrections

1. Provide a brief description of improvements initiated by the firm in response to a previous inspection, report of observations and/or a warning letter.
2. Report voluntary destructions, recalls, and similar actions since the prior inspection or during this inspection.
3. Report any follow-up to recalls identified during the inspection (may be by referencing Attachment B recall report).
4. Include recalls to specific objectionable conditions observed.
5. Provide the identity of person(s) responsible for the corrections.
6. Report any appropriate voluntary corrections in FACTS CARS

Exhibits and Samples Collected - List all exhibits attached. See IOM 594, Exhibits.

1. Include a listing of any samples collected.
2. Briefly, describe or title each exhibit and sample number attached. You should include in your description the number of pages for each Exhibit listing.

NOTE: For complex inspections a cross-reference from the FDA 483 and verbal observations to applicable exhibits and samples can be useful during further review.

Attachments - Attachments as referred to here are any material attached to and referred to in the EIR, which are not evidentiary in nature; such as assignments, Center provided protocols, etc. See IOM 527.02 for identification of non-evidentiary material attached to the EIR. Documents attached to the EIR may be referred to in the EIR and listed here, such as the FDA 482, FDA 483, copy of the FDA 463a, etc. (in form number order); but such documents/forms must not be numbered, altered from their issued state, bear adhesive identification labels, etc. See the opening sentence of IOM 594. List and attach copies of associated reports (Recall Attachment B Report, etc.).

Signature - All participants must sign the final narrative portion of the EIR. The prescribed format is to type each persons name, title, and district (or other affiliation) below the signature. In some cases immediate signature by all participants is not possible. An example as to how this can be accomplished is to forward an electronic "draft" copy of the EIR for all to read and approve, then followed or accompanied by the original signature sheet. When signed, return to the lead investigator for proper filing and routing. When using this method, a photocopy of the original signature page is made with the lead investigator's signature and temporarily attached to the EIR.

594 - EXHIBITS

Exhibits are materials collected from the firm and do not include FDA forms or copies of assignments. Exhibits should contribute to the objective of the assignment and the clarity of the report. They may include flow-plans, schematics, layouts, etc. If the materials collected from the firm are not needed as exhibits, they should be destroyed in accordance with district policy. Submit four copies of new or suspect labeling or other material collected as exhibits for labeling purposes. These should be mounted in a manner so complete sets are submitted, i.e., labels 1-10 in each of three sets. Identify records, labeling and documents with at least the Exhibits' number, date of EI and your initials. See IOM 527.02.

594.01 - Electronic information

Electronic information, databases or summary data from databases may be obtained from firms and evaluated during the course of an EI. This data may form the basis for observations or information included in the EIR. It is preferable to include a printed version and/or a summary of the data as an exhibit. When it is included as an exhibit to the EIR, it should be stored so as to protect the integrity of the data. See IOM 527.03 for procedures for collecting and identifying electronic data. Electronic media should be protected from extreme temperatures and most magnetic fields. Additional precautions may be necessary and you should be guided by your district procedures for storage of electronic data.

595 - ADDENDUM TO EIR

If your EIR requires correcting or clarification after it has been finalized, signed and distributed, you should prepare an addendum, with your supervisor's approval. The addendum should clearly identify itself with the EIR being added to, explain the necessity for the addendum, and clearly define what section(s) and page(s) are being revised. The addendum must be signed by the preparer.