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SUBCHAPTER 190 - REGULATORY NOTES

190 - OVERVIEW

Regulatory notes are the record of your daily investigatory efforts. They record your observations relevant to violations and active cases. They are the vital link between your findings and your subsequent testimony in court. Because of the data, which regulatory notes contain, such as information pertaining to open investigatory files, trade secrets, and personal information protected under the Privacy Act, they are confidential. Regulatory notes are government property. The notes cannot be released to anyone outside the Agency, except with the express permission of your management, and after following FDA's procedures. (See IOM 130)

See IOM 114 for guidance on administrative notes.

191 - USES OF REGULATORY NOTES

Accurate regulatory notes are to refresh your memory when reporting certain important details of a sample collection, inspection, and investigation. Notes also support the principle of "presumption of regularity", i.e., in the absence of clear evidence to the contrary, courts presume public officers properly discharge their official duties. Regulatory notes are useful as a means to refute assertions by defendants, witnesses or others. Regulatory notes also aid in defending lawsuits against FDA agents. This has been an issue of significance in a number of regulatory cases in the Federal Sector.

192 - REQUIREMENTS FOR REGULATORY NOTES

See IOM 100 for English language requirement. Regulatory notes should be made at the time of the event they represent. Regulatory notes must be original recordings of an activity, and may be handwritten (in ink) or electronic. Do not erase, edit or rewrite original notes. Any corrections should be identified.

Regulatory notes in electronic format must be authenticated to ensure document integrity. If electronic notes are utilized, adhere to agency directives and procedures to safeguard and file electronic notes. Positive identification of regulatory notes in electronic format is imperative. Regulatory notes can be printed, and each page initialed (handwritten initials) and dated by the investigator. If this procedure is used, the original disk can be identified with the firm name, dates, and investigator's initials; placed in a FDA-525 envelope; and then sealed with an Official Seal, FDA-415a. NOTE: See IOM 522 -Exhibits , for guidance on the identification and storage of electronic data obtained from inspected firms, and used as exhibits for the EIR. Regulatory notes must be accurate, objective, factual, and free of personal feelings or conclusions.

193 - REGULATORY ENTRIES

Regulatory notes should contain sufficient detail to refresh an investigator's memory regarding inspections, investigations and sample collections. They must include objectionable conditions, pertinent information about your activities during an operation, details of a sample collection, etc. If a checklist is used during an inspection, don't repeat that information in your regulatory notes. The checklist should be handled as part of the notes. Likewise, when relevant information is contained on an FDA form, or in an exhibit collected during an inspection, that information need not be repeated in your notes.

Regulatory notes should contain the substance of all significant discussions with people contacted during the activity; e.g., discussions of individual responsibility. When entering a direct quote in a notebook, such as a statement against self-interest, it is important the exact words be used to preserve the original intent of the individual and subject. Every quote of significance appearing in the final report should be in your regulatory notes since they are part of the source documents, which will support any regulatory or administrative action.

Regulatory notes should not contain purely administrative information. See IOM 114 for guidance on administrative notes.

194 - FORMAT FOR REGULATORY NOTES

Your regulatory notes must always be kept in a bound notebook. The reason for this is the continuity and integrity provided by bound pages. Loose-leaf and spiral bindings allow easy removal of pages, an invitation to vigorous and heated cross-examination on the witness stand. Bound notebooks also prevent lost or misplaced pages.

Regulatory notes in electronic format are a valuable tool to expediting the conduct of an inspection. They may be stored on computer disk, but must be preserved in a manner that ensures data integrity.

Regulatory notes whether written or electronic are subject to audit at any time; must be available for review; and must, on demand, be surrendered to your supervisors or other authorized personnel. Regulatory notes should be identified with your name, telephone number, and address to facilitate their return if lost. Advancing technology may increase the preservation options available. District policy should be followed regarding the preservation of all regulatory notes.

195 - RETENTION OF REGULATORY NOTES

Regulatory notes are to be appropriately identified with your name and the bracketing dates they cover before they are turned over for storage. Follow your District's policy regarding the maintenance of regulatory notes.

Based on your district's policy, regulatory notes (including computer disks) may be kept by you, filed with the final report, or kept by the district in a separate, designated file. At a minimum, regulatory notes must be retained for the same period of time as the inspection report, collection report or other investigational report, or until all court actions, including appeals, have been adjudicated.

If you leave FDA, or are transferred from your district, any regulatory notes in your possession must be identified and turned in to the district you are leaving. Districts are to retain regulatory notes as official records as outlined in the FDA Staff Manual Guide.

Regulatory notes prepared by headquarters' personnel during a field inspection/investigation are official records. Headquarters personnel are to follow their Center's policy regarding the retention of regulatory notes. In general, all regulatory notes should be maintained in the District or Center where the original report is filed.