Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 2.1 - REGULATORY NOTES

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Regulatory notes are the contemporaneous, sequential 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 Subchapter 1.4)

See IOM 1.2.4 for guidance on administrative notes.

 2.1.1 - 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.

 2.1.2 - REGULATORY NOTES CHARACTERISTICS

See IOM 1.1 for English language requirement. Regulatory notes should be accurate, objective, factual, and free of personal feelings or conclusions. Regulatory notes should be made at the time of the event they represent. Regulatory notes are original contemporaneous, sequential recordings of an activity, and may be handwritten (in ink) or electronic. Do not erase, edit or rewrite original notes. Do not leave excessive space between diary entries. Whether handwritten or electronic, any additions, deletions, or corrections to regulatory notes should be identified by strike through(strike through font for electronic notes) for deletions, brackets [    ] for additions and by initialing and dating your changes.

Electronic Regulatory notes: you should be able to identify and attest the electronic notes were taken by you to ensure document integrity. You should exercise good judgment when deciding if a change is contemporaneous or if change should be initialed and dated. For example, changes or backspacing to correct information ordinarily would not need initialing and dating as long as the changes were made contemporaneously with the activity being documented. Otherwise, you should initial and date the change. Adhere to agency directives and procedures to safeguard and file electronic notes. Regulatory notes can be printed, and each page initialed (handwritten initials) and dated by the investigator. If this procedure is used, the original disk or Compact Disk-Recordable (CD-R) can be identified with the firm name, dates, and investigator's initials; placed in a FDA-525 envelope or equivalent; and then sealed with an Official Seal, FDA-415a. NOTE: IOM 5.3.3 - Exhibits, for guidance on the identification and storage of electronic data obtained from inspected firms, and used as exhibits for the EIR.

 2.1.3 - REGULATORY ENTRIES

Regulatory notes should contain sufficient detail to refresh an investigator's memory regarding inspections, investigations and sample collections. They should 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 and attach it to your EIR. The checklist should be handled as part of the notes. See also 5.10.1. 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 your regulatory notes, 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 1.2.4 for guidance on administrative notes.

 2.1.4 - FORMAT FOR REGULATORY NOTES

Keep your handwritten regulatory notes in a bound notebook. Bound notebooks provide continuity and integrity and also prevent lost or misplaced pages. Loose-leaf and spiral bindings allow easy removal of pages, an invitation to vigorous and heated cross-examination on the witness stand.

Regulatory notes in electronic format are a valuable tool to expediting the conduct of an inspection. They may be stored on computer disk or CD-R, but should 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. The bound notebook in which your regulatory notes are kept should be identified with your name, telephone number, and address to facilitate their return if lost. To assist in the return of lost regulatory notes, include the following information in the bound notebook's inside cover or as a placard affixed to the back cover:

This book is the property of the U.S. Government.
If found, drop in mail box.
POSTMASTER: Postage guaranteed
Please return to: [Enter the appropriate district (or resident post's) mailing address here, including the zip code]

Advancing technology may increase the preservation options available. District policy should be followed regarding the preservation of all regulatory notes.

 2.1.5 - RETENTION OF REGULATORY NOTES

Identify your regulatory notes with your name and the inclusive 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 or CD-Rs) may be kept by you, filed with the final report, or kept by the district in a separate, designated file. At a minimum, retain regulatory notes 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, identify any regulatory notes in your possession and turn them 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.

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Page Last Updated: 08/20/2014
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