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Chapter A CHAPTER 1A – NOTES, RECORDS, AND INFORMATION 

 

1A.1 – REGULATORY NOTES .................................................................................................................. A-3

1A.1.1 – DEFINITION ............................................................................................................................. A-3

1A.1.2 –DIFFERENCE BETWEEN REGULATORY NOTES AND ADMINISTRATIVE NOTES .............................. A-3

1A.1.3 – USE OF REGULATORY NOTES ................................................................................................... A-3

1A.1.4 – QUALITY CHARACTERISTICS OF REGULATORY NOTES ............................................................... A-3

1A.1.4.1 – GENERAL CONSIDERATIONS ................................................................................................. A-3 

1A.1.4.2 – ENTRIES ............................................................................................................................... A-4 

1A.1.4.3 – FORMAT ............................................................................................................................... A-4 

1A.1.4.3.1 – HANDWRITTEN HARDCOPY REGULATORY NOTES ............................................................... A-4 

1A.1.4.3.2 – ELECTRONIC REGULATORY NOTES ..................................................................................... A-5 

1A.1.4.3.2.1 – ERN TAKEN IN ENSPECT .................................................................................................. A-5 

1A.1.4.3.2.2 – ERN TAKEN OUTSIDE OF ENSPECT ................................................................................... A-5 

1A.1.4.3.3 – SWITCHING BETWEEN HANDWRITTEN AND ELECTRONIC REGULATORY NOTES .................. A-5 

1A.1.5 – RECORDING REGULATORY NOTES IN RESTRICTED ENVIRONMENTS .......................................... A-6

1A.1.6 – RETENTION OF REGULATORY NOTES ....................................................................................... A-6

1A.2 - RECORDS MANAGEMENT ............................................................................................................ A-7

1A.2.1 – TYPES OF RECORDS ................................................................................................................. A-7

1A.2.1.1 – PERMANENT RECORDS ......................................................................................................... A-7 

1A.2.1.2 – TEMPORARY RECORDS ......................................................................................................... A-7 

1A.2.1.3 – INTERMEDIARY RECORDS ..................................................................................................... A-7 

1A.2.1.4 – TRANSITORY RECORDS ......................................................................................................... A-7 

1A.2.2 – RECORDS RETENTION .............................................................................................................. A-8

1A.2.3 – ADDITIONAL INFORMATION ABOUT RECORDS MANAGEMENT ................................................ A-8

1A.2.4 - SPECIFIC RECORDS INVESTIGATORS HANDLE AND CREATE ........................................................ A-8

1A.2.4.1 - REGULATORY NOTES ............................................................................................................. A-8 

1A.2.4.2 - ADMINISTRATIVE NOTES ....................................................................................................... A-9 

1A.2.4.3 - E-MAIL .................................................................................................................................. A-9 

1A.2.4.4 - COLLECTION REPORTS AND LAB ANALYTICAL PACKAGES ........................................................ A-9 

1A.2.4.5 - MEMORANDA ..................................................................................................................... A-10 

1A.2.4.6 - RECALL AUDIT CHECK REPORTS ........................................................................................... A-10 

1A.2.4.7 - CONSUMER COMPLAINTS ................................................................................................... A-10 

1A.2.4.8 - CORRESPONDENCE ............................................................................................................. A-10 

1A.2.4.9 - ATTACHMENTS ................................................................................................................... A-11 

1A.2.4.10 - EXHIBITS ........................................................................................................................... A-11 

1A.2.4.11 - ADDITIONAL DOCUMENTS COLLECTED DURING INSPECTION ............................................. A-11 

1A.2.4.12 - PHOTOGRAPHS ................................................................................................................. A-11 

1A.2.5 - LITIGATION HOLDS OR INJUNCTIONS ...................................................................................... A-11

1A.2.5.1 LITIGATION HOLDS ................................................................................................................ A-11 

1A.2.5.2 – INJUNCTIONS ..................................................................................................................... A-12 
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1A.2.5.3 – ADDITIONAL INFORMATION ............................................................................................... A-12 

1A.3 – INFORMATION DISCLOSURE ..................................................................................................... A-12

1A.3.1 – SUBPOENA ............................................................................................................................ A-13

1A.3.2 – REQUESTS BY THE PUBLIC ..................................................................................................... A-13

1A.1.3 – SHARING NON-PUBLIC INFORMATION WITH OTHER GOVERNMENT OFFICIALS ...................... A-13

1A.3.4 – FREEDOM OF INFORMATION ACT (FOIA) ............................................................................... A-14

1A.3.4.1 – REQUESTS FOR DOCUMENTS .............................................................................................. A-15 

1A.3.5 – INTERNAL FDA DOCUMENTS ................................................................................................. A-15

1A.4 – ENGLISH LANGUAGE REQUIREMENT ........................................................................................ A-15

1A.5 – FULL NAME REQUIREMENT ...................................................................................................... A-16

INDEX ................................................................................................................................................. A-17

 
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1A.1 – Regulatory Notes 

1A.1.1 – Definition 

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. Your regulatory notes are confidential because of the 

data they contain (e.g., information pertaining to open investigatory files, trade secrets, and personal 

information protected under the Privacy Act). Regulatory notes are government property and are 

releasable under the FOIA following FDA's procedures (See IOM 1A.3). 

1A.1.2 –Difference between Regulatory Notes and Administrative Notes 

Regulatory notes should not be confused with administrative notes. Administrative notes are purely 

administrative in nature and may include information related to travel, expenses, fiscal data, 

timekeeping, and documentation of meetings outside of regulatory operations. Regulatory notes should 

not contain purely administrative information, and they should not be maintained together. 

Administrative notes can be documented in a separate section of the same bound notebook where your 

regulatory notes are kept or in a separate administrative diary.

1A.1.3 – Use of Regulatory Notes 

Accurate regulatory notes are to document evidence and to refresh your memory when reporting

certain important details of a field operation, such as a sample collection, consumer complaint, 

inspection, or investigation. Regulatory notes are the source record upon which your reports will be 

prepared. Regulatory 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 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 several 

regulatory cases in the federal sector.

1A.1.4 – Quality Characteristics of Regulatory Notes

1A.1.4.1 – General Considerations 

See IOM 1A.4 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 electronically. (See IOM 1A.1.5 for information on what 

to do under rare circumstances when regulatory notes cannot be taken contemporaneously such as 

when entering a restricted environment.)

You should exercise good judgment when deciding if a change is contemporaneous, or if a change 

should be initialed and dated. For example, changes or backspacing to correct information as it is 

being written ordinarily would not need initialing and dating if the changes were made 

contemporaneously with the activity being documented. However, if you are returning to the 
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information to change it after it was initially recorded, you should initial and date the change. (See 

IOM 1A.1.4.3.1 for information on how to document corrections in your regulatory notes.)

1A.1.4.2 – Entries 

Regulatory notes should contain sufficient detail to refresh an investigator's memory regarding field 

activities, such as inspections, investigations, consumer complaints, and sample collections. They 

should include descriptions of your activities during the operation and your findings, such as 

objectionable conditions observed, or details of a sample collection. 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 5.11.1. 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. The act of issuing the form, collection of the 

exhibit, your review of the record, etc., should be recorded in your regulatory notes.

Regulatory notes should contain the substance of all significant discussions with people contacted 

during the activity, (e.g. discussions of individual responsibility and refusals). When entering a direct 

quote in your regulatory notes, such as a statement against self-interest, it is important that 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 it is part of the 

source documents, which will support any regulatory or administrative action.

1A.1.4.3 – Format 

You may choose to take your regulatory notes as handwritten notes (bound journal), electronic, or 

as a combination of the two. Follow your management’s direction. 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 supervisor or other authorized personnel. Advancing technology 

may increase the preservation options available. District policy should be followed regarding the 

preservation of all regulatory notes.

1A.1.4.3.1 – Handwritten Hardcopy Regulatory Notes 

When taking handwritten regulatory notes, use a bound notebook. Bound notebooks provide 

continuity and integrity, and 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. (See 1A.1.5 for information on situations where taking regulatory notes in your 

bound notebook may not be feasible.) 

Do not erase, edit, or rewrite original notes. Do not leave excessive space between diary entries. 

Any additions, deletions, or corrections to handwritten regulatory notes should be identified by 

strike-through for deletions, brackets [ ] for additions, and by initialing and dating your changes.

The bound notebook in which your handwritten regulatory notes are kept should be identified 

with your name, telephone number, and address to facilitate their return if lost. To assist in the 
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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 mailbox.

POSTMASTER: Postage guaranteed

Please return to: [Enter the appropriate district (or resident post's) mailing address here, 

including the zip code]

1A.1.4.3.2 – Electronic Regulatory Notes 

You have the option of taking regulatory notes electronically as long as you can identify and 

attest that the electronic notes were taken by you, and you can ensure document integrity. 

Electronic regulatory notes (ERN) can be taken in eNSpect (preferred method), or outside of 

eNSpect, in software such as Microsoft OneNote or Word. You should contact your supervisor if 

you have questions on which software to use. 

1A.1.4.3.2.1 – ERN Taken in eNSpect 

eNSpect provides the capability to record and store electronic notes. This is ORA’s preferred 

method for taking regulatory notes electronically. See 

https://fda.sharepoint.com/sites/ORAOPOP/OISM/OISMExternal/Systems/eNSpect/SitePages/Home.aspx for the complete User 

Guide and Frequently Asked Questions section for additional information.

1A.1.4.3.2.2 – ERN Taken Outside of eNSpect 

If using software/programs other than eNSpect, any additions, deletions, or corrections to 

regulatory notes should be identified by using strikethrough font for deletions, brackets [ ]

for additions, and by initialing and dating your changes. Notes should be stored in a method 

where they are preserved in a manner that ensures data integrity and are retrievable if 

needed, for example, uploaded into eNSpect or saved on electronic storage media. Adhere 

to agency directives and procedures to safeguard and file electronic notes. Regulatory notes 

taken outside of eNSpect can be printed. If printed, you should be able to attest to the fact 

that the notes are accurate, complete, and were taken contemporaneously. This includes 

electronically signing the ERN file before printing or applying handwritten initials and date to 

each printed page. If this procedure is used, the original electronic storage media, can be 

identified with the firm name, dates, and investigator's initials; placed in an FDA-525 

envelope or equivalent; and then sealed with an Official Seal, FDA-415a. NOTE: See IOM 

5.3.3 - Exhibits, for guidance on the identification and storage of electronic data. Regulatory 

notes are not exhibits to the EIR (See IOM 1A.1.6 for Retention of Regulatory Notes). 

1A.1.4.3.3 – Switching between Handwritten and Electronic Regulatory Notes 

At your management’s discretion, you can switch between taking regulatory notes

electronically and in your handwritten journal. However, it is important to document when 
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switching between the two forms because your regulatory notes are meant to be recorded 

contemporaneously. When switching between the two formats during a single operation, 

make a note in both formats that you will be taking notes using the other format and why 

(e.g., “Entering production room floor to observe sanitation – notes to be taken via bound 

journal/handwritten. Will switch back to eNSpect ERN upon return to conference room.”). 

Be sure to include the date and time at which you are switching. Repeat the same process 

each time you switch between formats. This practice ensures that there is no unaccountedfor gap in your regulatory notes for the same operation (e.g., inspection, investigation).

1A.1.5 – Recording Regulatory Notes in Restricted Environments 

In rare circumstances, you may be unable to take regulatory notes using your notebook or electronic 

note-taking device because doing so might introduce contamination from your notebook into the 

environment (e.g., pharmaceutical clean rooms, egg-laying hen houses) or from the environment into 

your notebook (e.g., environmental sampling of manure pits during egg inspections, drug manufacturing 

areas where high-potency, cytotoxic, or β-lactam drugs are exposed). Additionally, if you use an 

electronic notetaking device, you may be unable to use it in environments that present an explosion 

hazard.

You should attempt to take contemporaneous notes in the most reasonable manner possible. Make a 

note in your official regulatory notes that you will be taking notes using another method and the reason 

(e.g. “Entering cleanroom to observe sterile operations – notes to be taken on sterile cleanroom paper 

provided by firm to prevent contamination”). If taking notes on unbound sheets of paper, please refer 

to supervisory guidance.

If you are unable to take notes in any manner, you should record your recollection of the events and/or 

observations in your regulatory notebook as soon as you are able to. Include the reason you could not 

contemporaneously take notes in your regulatory notebook and the time between the event and/or 

observations and the notes. 

After the inspection, preserve the notes according to your division policy and in consultation with 

supervisor guidance.

1A.1.6 – Retention of Regulatory Notes 

Identify your regulatory notes with your name and the inclusive dates they cover before they are turned 

over for storage (does not apply to ERN taken within eNSpect). Follow your district policy regarding the 

maintenance of regulatory notes.

Based on your district policy, regulatory notes may be kept by you, filed with the final report, or kept by 

the district in a separate, designated file. 
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If you leave the 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 (see SMG 3291.1).

Regulatory notes prepared by center personnel during a field inspection/investigation are official 

records. Center 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.

1A.2 - Records Management 

A record as defined by the National Archives and Records Administration (NARA), the Federal agency 

that oversees all records management rules and regulations, includes all recorded information, 

regardless of form or characteristics, made or received by a Federal agency under Federal law or in 

connection with the transaction of public business and preserved or appropriate for preservation by that 

agency or its legitimate successor as evidence of the organization, functions, policies, decisions, 

procedures, operations, or other activities of the United States Government or because of the 

informational value of data in them.” (44 U.S.C. 3301). Records must be retained until they are ready for 

disposition (instructions for managing records when not needed for agency business) and at what point 

they can be destroyed or transferred in accordance with their Record Schedule. 

1A.2.1 – Types of Records 

Different types of records require distinct maintenance and handling based on their record schedule and 

the type of record. This section describes the main records disposition categories.

1A.2.1.1 – Permanent Records 

Records that contain historically significant materials, provide evidence of agency accomplishments, 

or document important events in national history, and as a result will be preserved by NARA.

1A.2.1.2 – Temporary Records 

Records with a temporary disposition that will eventually be destroyed or deleted when all relevant 

business needs have expired.

1A.2.1.3 – Intermediary Records 

Records of an intermediary nature, meaning that they are created or used in the process of creating 

a subsequent record. To qualify as an intermediary record, the record must also not be required to 

meet legal or fiscal obligations, or to initiate, sustain, evaluate, or provide evidence of decisionmaking.

1A.2.1.4 – Transitory Records 

Records required only for a short time (generally less than 180 days) and are not required to meet 

legal or fiscal obligations, or to initiate, sustain, evaluate, or provide evidence of decision-making.
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1A.2.2 – Records Retention 

Per current FDA policy, records must be maintained for the duration of their retention period in 

accordance with their corresponding record schedule in the format that they are received. For example, 

paper and electronic records received from firms must be maintained in accordance with their retention 

periods even if they are scanned and/or uploaded into eNSpect. The official record is the original paper 

or electronic record received from the firm. 

All records must be maintained for a certain amount of time and in a certain manner. See corresponding 

section of the IOM for specific information about how to handle many of the most common record 

types. Contact your local administrative and/or compliance branch for additional guidance about 

specific record retention policies including record schedules, maintenance, destruction, transfer, and 

storage.

Due to government-wide mandates to transition away from paper records, all records should be 

collected, created, stored, and distributed electronically to the fullest extent possible. Electronic records 

should not be printed for storage--electronic record management solutions should be pursued instead. 

Some situations, such as issuing FDA Forms (i.e., FDA-482, FDA-483, FDA-484) or Firm Correspondence 

(FMD-145), may require the creation of a physical record.

1A.2.3 – Additional Information about Records Management 

Additional records management information can be found in the links below:

• Records Definitions: https://www.archives.gov/files/records-mgmt/rm-glossary-of-terms.pdf 

• Transitory and Intermediary Record Guidance: https://www.archives.gov/files/recordsmgmt/grs/grs05-2.pdf

• ORA Records SharePoint: Records Management - Home (sharepoint.com)

• FDA Records Control Schedules: https://www.archives.gov/recordsmgmt/rcs/schedules/index.html?dir=/departments/department-of-health-and-humanservices/rg-0088

• ORA Standard National File Plan: 

http://qmis.fda.gov:80/mc/index.cfm?initialRequest=http%3A%2F%2Fqmis.fda.gov%3A80%2Fm

c%2Fmain%2Findex.cfm%3Fevent%3DshowFile%26ID%3DDMTEXEDZ3JEVRILSFG%26static%3Df

alse 

1A.2.4 - Specific Records Investigators Handle and Create

Examples of records you will likely handle in your career as a CSO can be found in this section. 

1A.2.4.1 - Regulatory Notes 

See IOM 1A.1.
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1A.2.4.2 - Administrative Notes 

See IOM 1A.1.2.

1A.2.4.3 - E-mail 

E-mails are official government records and are required to be retained appropriately. Most FDA 

employee emails are saved within outlook for seven years after employees depart the agency. This 

policy coincides with the HHS email policy and NARA GRS 6.1 record retention requirement for 

emails.

If any emails in your possession are associated with cases or are under legal hold, they may require 

longer than a seven-year retention. In such cases, an alternate electronic repository may be required 

to store the corresponding emails. For additional information or guidance, communicate with your 

local administrative branch and/or the compliance branch overseeing the case.

Capstone employee emails are saved permanently then transferred to NARA; however, this only 

applies to a small number of senior leaders. 

See additional email policies:

• HHS email 

• Policy: https://intranet.hhs.gov/policy/records-management-email#7.11

• NARA Email Record Schedule: https://www.archives.gov/files/records-mgmt/grs/grs06-

1.pdf

• NARA file formats for permanent electronic records: https://www.archives.gov/recordsmgmt/policy/transfer-guidance-tables.html

• Information about Capstone employee emails: https://www.archives.gov/recordsmgmt/email-management/capstone-training-and-resources.html 

1A.2.4.4 - Collection Reports and Lab Analytical Packages 

Collection reports include documents collected from a firm and documents created by the FDA 

regarding the collection of a product, environmental, or documentary sample. Collection reports 

should remain intact and be stored at the home district of the firm where the sample was collected 

or the office from which any regulatory action would be executed.

Local district procedures should be followed for storing collection reports; however, in most cases 

physical collection reports of product and environmental samples should be stored separately from 

physical inspection records, while documentary samples should be stored with corresponding 

inspection records.

Lab analytical packages demonstrate laboratory results from a sample collection, and if physical 

records exist, they should be stored with their corresponding collection report at the home district 

of the firm where the sample was collected, or the office from which any regulatory action would be 

executed. 

All efforts should be made to maintain Collection Reports and Lab Analytical Packages electronically 

such as in Compliance Management Systems (CMS).
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1A.2.4.5 - Memoranda 

Memoranda may include investigational or administrative subject matter and should be retained 

according to their content. Investigational memoranda should be stored at the home district of the 

firm visited or referenced in the memorandum and may include investigations, tracebacks, 

consumer complaints, Reportable Food Registry Responses, Out-Of-Business, etc.

Administrative memoranda should be stored appropriately and may include topics such as 

Exceeding Travel Allowance, Internal Decision Memos, Other than Coach Class Travel 

accommodations, etc. All efforts should be made to maintain memoranda electronically, such as in 

CMS, eNSpect, or Enterprise Content Management System (ECMS).

1A.2.4.6 - Recall Audit Check Reports 

The results of recall audit checks are reported on FDA Form 3177, "Recall Audit Check Report." See 

IOM Exhibit 7-3. Divisions have the option of completing the form FDA 3177 electronically or as a 

hard copy. The preferred method is electronically.

The form FDA 3177 will be routed through your supervisor to the recall coordinator at the division 

monitoring the recall, who will store the official signed form in the recall file. (IOM 7.3.2.4)

1A.2.4.7 - Consumer Complaints 

Per SOP 000544, all consumer complaint records are stored electronically in FACTS consumer 

complaint files. Hard copy files and documents provided by the complainant are stored in the 

district firm files. This can be electronic, or paper based.

If documents, records, or photographs are received from the complainant, the documentation is 

scanned and sent to the appropriate program for filing per program procedures, and the hard copy 

is sent to the firm’s home district for filing. See 

http://qmis.fda.gov/mc/index.cfm?initialRequest=http%3A%2F%2Fqmis.fda.gov%3A80%2Fmc%2Fm

ain%2Findex.cfm%3Fevent%3DshowFile%26ID%3D7QYTPC6FZFEZBO7GPP%26static%3Dfalse#/

1A.2.4.8 - Correspondence 

Correspondence typically includes electronic or physical mail among FDA employees, or between 

FDA employees and the public or regulated industry.

If the correspondence is received from regulated industry in response to an FDA Form 483 or 

regulatory meeting, or is related to an inspection or investigation activity, then the correspondence 

should be filed in the Establishment File or Compliance File related to the activity. Physical 

correspondence should be stored in the home district of the associated firm. Electronic 

correspondence should be stored in the appropriate electronic repository per ORA or program 

policy.

Firm management should be requested to provide their inspection or investigation responses via 

program division email boxes as per program policy. Correspondence that is not associated with an 

inspection or investigation activity should be filed per ORA, local, or program policy. All efforts 
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should be made to maintain correspondence electronically such as in CMS, eNSpect, ECMS, RES 

(Recall Enterprise System), or other electronic repository.

1A.2.4.9 - Attachments 

Documents attached to the EIR not provided by the firm during the inspection and referred to in the 

EIR, may be referred to under the attachment heading. 

See IOM 5.3.8 and 5.11.6 for additional information.

1A.2.4.10 - Exhibits 

Exhibits are materials collected from the firm after the FDA Form 482 Notice of Inspection or FDA 

Form 482d Request for FSVP Records is issued and before the FDA Forms 483, 483a, or 4056 are 

issued or the inspection is closed out. 

See IOM 5.3.8 and 5.11.5 for additional information on records obtained.

1A.2.4.11 - Additional Documents Collected during Inspection 

Materials not used in an EIR do not need to be kept under an official file plan. 

Hard copy documents collected from the firm that are not needed as exhibits should be destroyed in 

accordance with your program division or office policy, (i.e. shredded or placed in a designated 

shredder bin). If the inspection is ongoing, you may return such documents to the firm.

Electronic documents obtained on storage media containing exhibits should be handled per IOM 

5.3.8.3.2.2. Documents not used in the EIR should not be deleted from storage media. 

1A.2.4.12 - Photographs 

The photographs included and described in the EIR are considered the official exhibit and are 

maintained in the eNSpect system. See IOM 5.3.4 for additional information on preserving 

photographic evidence.

1A.2.5 - Litigation Holds or Injunctions 

There are circumstances where the FDA must maintain records beyond the Records Management

requirements. These circumstances are generally related to legal cases pending with the agency. You 

may receive a notice that there is a litigation hold or injunction regarding destruction of records. This 

includes deletion of e-mails related to a particular matter. Read these notices carefully if you receive 

one.

1A.2.5.1 Litigation Holds 

Litigation holds are holds placed on records. The request to hold records comes from the FDA OCC 

to ensure that records associated with an ongoing legal action are not destroyed. Records under 

litigation hold cannot be deleted or destroyed while the legal hold is active. If you are notified 

directly of a litigation hold on records in your possession, you should preserve those records until 
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you are notified that the litigation hold is no longer active. For the purposes of supporting the 

preservation of ORA records under litigation hold, there is a consolidated list of known litigation 

holds and added it to the ORA Records Management SharePoint Site. (See link below for this list 

and additional guidance.) 

1A.2.5.2 – Injunctions 

Injunctions are legal actions with potentially extensive or indefinite time periods until completion or 

lifting of the injunction, especially in the case of permanent injunctions. Records that lead to the 

development of an injunction cannot be destroyed prior to the end of the injunction, and therefore, 

must be preserved in a similar manner as litigation holds. For the purposes of supporting the 

preservation of ORA records under injunction, there is a consolidated list of known injunctions on 

the ORA Records Management SharePoint Site. (See link below for this list and additional guidance.) 

1A.2.5.3 – Additional Information 

The litigation holds and injunctions lists linked below may not include all existing litigation holds or 

injunctions. If you are aware of any additional litigation holds or injunctions, you must preserve all 

associated records, regardless of their inclusion on these lists.

ORA Records Management SharePoint Site with litigation hold and injunction lists and additional 

relevant guidance can be found at: https://fda.sharepoint.com/sites/ORA-OMInternal/ORARecManagement/SitePages/RM%20Legal%20Holds.aspx?csf=1&web=1&e=ej0cGs

1A.3 – Information Disclosure 

Sharing of information, regardless of the manner, must comply with FOIA, other applicable laws such as 

the Privacy Act and FDA procedures. Do not disclose any non-public information (NPI) (written or 

verbal) obtained during FDA official duties, unless you are authorized to do so by ORA’s Division of 

Information Disclosure Policy (DIDP). Do not release any originals or copies of reports, memos, 

regulatory notes, forms (e.g., FDA-483, 484, 464, etc.), confidential or trade secret information obtained 

by a firm, or similar investigational documents to anyone outside the agency without express 

concurrence and appropriate authorization of division or headquarters management, the Office of the 

Chief Counsel (OCC), or information disclosure personnel. Unauthorized disclosure of confidential 

commercial or financial information, trade secrets, or personal privacy information could be a civil or 

criminal violation and may carry legal or other consequences for the disclosing official.

NPI includes information exempt from public disclosure under FOIA (see also FDA regulations under 21 

CFR Part 20 Subpart D - Exemptions), as well as any other information prohibited from public disclosure 

under federal law or regulation, including the Privacy Act and the Trade Secrets Act (See other CFR 

disclosure references for an inexhaustive list). Examples of non-public information include confidential 

commercial information, trade secret information, pre-decisional FDA communications, investigative 

information, enforcement information, and personal privacy information. Confidential information in 

particular includes commercial or financial information "customarily kept private, or at least closely 

held," by the submitter. Submitted confidential information that FDA determines is exempt from public 
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disclosure will be held in confidence by FDA unless required or authorized by regulation, statute, or 

court order.

Disclosure of non-public information must follow FDA regulations:

• 21 CFR 20.85 – other federal government departments or agencies

• 21 CFR 20.88 – state/local 

• 21 CFR 20.89 – foreign

• 21 CFR Part 20 – Freedom of Information Act (FOIA)

• 21 CFR Part 21 – Privacy Act 

• Other disclosure procedures found on the ORA Information Disclosure page

If non-public information is inadvertently disclosed, follow ORA’s Addressing Inadvertent Disclosures 

SOP. Any information disclosure questions should be directed to DIDP at ORAinfoshare@fda.hhs.gov.

1A.3.1 – Subpoena 

If you are served a subpoena (commanding your appearance in court) or a subpoena duces tecum, 

(commanding the production of any record or testimony, or the giving of information relating to official 

FDA matters), immediately advise your supervisor and ORA’s Division of Information Disclosure (DIDP) 

(ORA OSPOP Testimony – Info Sharing Team) at ORAinfoshare@fda.hhs.gov. A testimony specialist will 

instruct you about the proper procedures and actions, so you are able to comply with the subpoena. 

(See 21 CFR § 20.1, § 20.2 and the Regulatory Procedures Manual (RPM) chapter 10-11, "Testimony; 

Production of Records; Certification of Records.")

1A.3.2 – Requests by the Public 

See IOM 1A.1.4 regarding information requested by the public under FOIA. For procedures for sharing 

non-public information with federal, state, local, or foreign government officials, see IOM 1A.1.3.

If a complainant requests sample results, see IOM 8.1.3. For procedures on the release of EIRs to the 

establishment inspected, see Field Management Directive (FMD)-145. For procedures on the disclosure 

of analytical results to establishments pursuant to Section 704(d) of the FD&C Act [21 U.S.C. 374 (d)],

see IOM 4.6.2.59 and FMD 147. 

1A.3.3 – Sharing non-public information with other government officials 

If you receive requests for non-public information from officials of other federal agencies or from state 

or local officials, contact your designated state liaison or DIDP at ORAinfoshare@fda.hhs.gov. If you 

receive requests for non-public information from foreign officials contact International Federal 

Engagement at “ORA OP International & Federal Engagement Group” 

oraopdiintlandfederalgroup@fda.hhs.gov.

Follow the current guidance: 

• SMG 2830.3 Sharing Non-Public Information with Foreign Government Officials 
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• SMG 1410.65 Disclosure of Trade Secret Information to Foreign Governments

• SMG 1410.66 Delegation of Authority for Disclosure of Non-Public Information to Foreign 

Government Officials or Receipt of Non-Public Information from Foreign Government Officials

• MAN-000006 Regulatory Procedures Manual Chapter 3: Commissioning and Information 

Sharing (Specifically Section 3-6-4 Sharing Non-Public Information with Federal Government 

Officials and Section 3-6-3 Sharing Non-Public Information with State and Local Government 

Officials)

FDA's practice regarding requests for non-public information (NPI) from state government officials and 

agencies is governed by 21 CFR 20.88. All exchanges of confidential commercial or financial information 

with all state government officials must be authorized through DIDP and made pursuant to a written 

confidentiality agreement with the government official or officials seeking to access the non-public 

information. 

Requests for NPI from foreign regulatory authorities are governed by 21 CFR 20.89. These 

confidentiality agreements are established and managed by the Office of Global Policy and Strategy and 

can be found on the confidentiality agreement webpage.

Requests for non-public information from other federal government departments and agencies are 

governed by 21 CFR 20.85. All exchanges of non-public information with federal government officials 

outside of DHHS must be authorized through DIDP pursuant to a written confidentiality arrangement 

with the government official.

For any questions regarding the sharing of non-public information with a state, local, or federal entity, 

please contact DIDP at ORAinfoshare@fda.hhs.gov.

1A.3.4 – Freedom of Information Act (FOIA) 

The Public Information section of the Administrative Procedures Act, 5 U.S.C 552, more commonly 

known as the FOIA, adopts a general rule that, except where specifically exempt, all documents in 

government files shall be made available to the public. The regulations exempt certain information, such 

as personal privacy, deliberative process, open investigatory, as well as a company’s trade secrets or 

confidential commercial or financial information.

You can find information about disclosure and confidentiality of information related to FDA records and 

documents in 21 CFR Parts 20 and 21, 21 CFR 71.15, 170.102, 312.130, 314.430, 514.11, 514.12, 601.50, 

814.9, and within other documents and statutes as detailed on the ORA Information Disclosure page. In 

addition to the FOIA, other acts such as the , PHS Act, and 18 U.S.C. 1905 also contain information 

relating to the confidentiality of information in government files. Note that special care should also be 

taken to protect the identity of confidential sources, see IOM 5.2.9.2.3. 
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All ORA staff must adhere to FDA's laws and procedures regarding the maintenance of confidentiality of 

non-public information. 

1A.3.4.1 – Requests for Documents 

If you receive requests for information, you may direct the requester to the FDA Electronic Reading 

Room (https://www.fda.gov/regulatory-information/freedom-information/electronic-readingroom). If answers cannot be found, the requester may be directed to submit a FOIA request at 

https://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/ucm2007229.htm. If 

your office receives a request, forward an electronic copy of the request to the director of the 

Division of Freedom Information (DFOI). 

1A.3.5 – Internal FDA Documents 

FDA records that are intended for internal use only may contain information protected from disclosure 

to the public by a FOIA exemption. Examples include work plans, internal decision memos, internal 

federal agency emails, and attorney-client communication. Do not disclose such records without 

consultation from an information disclosure expert in DIDIP. If you receive requests for internal 

documents, or for parts of them, refer to IOM 1A.1.4 and IOM 1.10.2.5.

1A.4 – English Language Requirement 

Records or Federal Records are defined in 44 U.S.C. 3301 as including “all recorded information, 

regardless of form or characteristics, made or received by a Federal agency under Federal law ...” which 

includes regulatory notes, memoranda, inspection reports, emails, and official government forms e.g. 

SF-71, FDA-482-FDA-483, etc. made or received by an agency of the United States Government under 

Federal law or in connection with the transaction of public business and preserved or appropriate for 

preservation by that agency or its legitimate successor as evidence of the organization, functions, 

policies, decisions, procedures, operations or other activities of the Government or because of the 

informational value of the data in them (44 U.S.C. 3301). (See also § 1222.10 of this part for an 

explanation of this definition).

All official FDA documents generated during your routine duties shall be completed in English. This 

requirement is necessary to facilitate efficiency in the workplace. For instance, many of your work 

products used in support of FDA’s regulatory process are subject to review and auditing by your 

supervisor, utilized by your co-workers, and others, including the public, in that they are releasable 

under the Freedom of Information Act (FOIA). The agency does not have the resources to assure the 

accurate and timely English translation of documents written in a non- English language in order to 

facilitate their use in the conduct of official business. English is generally considered to be the common 

language of the U.S.; therefore, it is necessary to standardize the language utilized in the production of 

official FDA documents.

Additionally, FDA imposes English only requirements on the public for information submitted to the 

agency. For example, 21 Code of Federal Regulations section 803.13(a) (English Reporting Requirement) 
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states that all reports required in this part which are submitted in writing or electronic equivalent shall 

be submitted to FDA in English.

1A.5 – Full Name Requirement 

Full name means the person’s first name, middle initial, last name and any appropriate suffixes 

(e.g., Jr. Sr.). If an establishment inspection report is associated with the operation, the fact that 

there is no middle initial should be explained in the Individual Responsibility and Persons 

Interviewed section of the report (see IOM 5.11.4.3.7).
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Index

A

Administrative Actions .......................................... A-4

Administrative Notes.............................. A-1, A-2, A-8

C

Code of Federal Regulation ................................. A-15

Conduct ............................................................... A-15

D

Destruction ...................................................A-8, A-11

E

Electronic Regulatory Notes............A-1, A-4, A-5, A-6

eNSpect..................A-1, A-4, A-5, A-6, A-8, A-10, A-11

Evidence.......................................A-2, A-7, A-11, A-15

Expenses................................................................ A-2

F

Freedom of Information ...A-2, A-12, A-13, A-14, A-15

Freedom of Information Act (FOIA)... A-2, A-13, A-14, 

A-15

H

Hazard.................................................................... A-6

O

Organization .................................................A-7, A-15

P

Permanent Injunction .......................................... A-12

Property..........................................................A-2, A-4

Public Health Service (PHS) Act ........................... A-14

R

Record Schedule ..................................... A-7, A-8, A-9

Records...A-1, A-6, A-7, A-8, A-9, A-10, A-11, A-12, A13, A-14, A-15

Records Management ......... A-1, A-6, A-8, A-11, A-12

Records Retention ..........................................A-1, A-7

Regulatory Notes. A-1, A-2, A-3, A-4, A-5, A-6, A-8, A12, A-15

Reporting ............................................ A-2, A-10, A-15

Responsibility......................................................... A-3

S

Sampling .................................A-2, A-3, A-5, A-9, A-13

T

Testimony .....................................................A-2, A-13

Training.................................................................. A-9

Travel ............................................................A-2, A-10

U

United States Code (U.S.C.) .......A-7, A-13, A-14, A-15