FDA Form 4003 is a records request the Food and Drug Administration sends to a regulated establishment, asking for specific documents in advance of, in place of, or as follow-up to an inspection. The form is titled “FDA Records Request” and is authorized by section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.1U.S. Food and Drug Administration. FDA Records Request (Form 4003) If one arrives at your facility, your obligation is to collect what it describes and send it to the named FDA contact by the deadline printed on the form.
What the Form Actually Is
You do not fill out Form 4003 on your own initiative. The FDA fills it out and sends it to you. It identifies your establishment by name and address, names a specific FDA contact, describes the records being requested, states the reason, and sets a response deadline. Your job is to read it, gather the documents, and return them.
One quick boundary. If you were looking for the Report of Assembly of a Diagnostic X-Ray System, that is FDA Form 2579, filed by assemblers of X-ray equipment under 21 CFR 1020.30.2U.S. Food and Drug Administration. Diagnostic X-ray Reports of Assembly That is a different document with a different purpose, and Form 4003 will not help you meet an assembler’s reporting obligation.
Why the FDA Sent It to You
The form itself lists the possible reasons. It may be pre-inspection preparation, so investigators can review documents before arriving. It may support a Remote Interactive Evaluation your establishment agreed to. It may be inspection follow-up, where investigators need additional records to close out findings from a visit. It may relate to a marketing submission you filed and the agency’s review of supporting records. It may be verification that deficiencies from a prior inspection were corrected. Or it may fall under general information gathering.
The statutory authority is 21 U.S.C. § 374(a)(4), which lets the FDA request records from any person who owns or operates an establishment engaged in manufacturing, preparing, compounding, or processing a drug or device, either in advance of or in lieu of a physical inspection.3Office of the Law Revision Counsel. 21 USC 374 – Inspection The statute requires the request to describe what the agency wants and explain why.
Who Gets One
Any FDA-regulated establishment can. The statute covers facilities that manufacture, process, pack, or hold drugs, devices, food, cosmetics, or tobacco products for interstate commerce.3Office of the Law Revision Counsel. 21 USC 374 – Inspection In practice, drug and medical device manufacturers see these requests most often, particularly around remote assessments and risk-based surveillance, but food facilities, cosmetics manufacturers, and contract testing laboratories are not exempt.
The form is addressed to a named individual, usually the owner, operator, quality director, or the regulatory affairs contact the FDA has on file. If it lands on the wrong desk, route it to the right person the same day. The response clock is already running.
How to Respond
Two things on the form drive your response: the deadline and the delivery method. Email is the default, and the FDA contact’s email address appears directly on the form. The agency asks you to send the requested records electronically by the date listed.1U.S. Food and Drug Administration. FDA Records Request (Form 4003) If email will not work for you because of file size, security restrictions, or format, contact the FDA representative on the form to arrange mailing.
Once the FDA receives your records, the statute requires the agency to send you a confirmation of receipt.3Office of the Law Revision Counsel. 21 USC 374 – Inspection If that confirmation does not arrive within a reasonable time, follow up with the contact listed on the form.
Keep copies of what you sent, the email or mailing receipt, the original Form 4003, and the FDA’s receipt confirmation once it comes in. If a question later arises about what you provided or when, that file is your record.
If Some Records Don’t Exist
Say so, in writing, in your response. The form instructs you to state that the records do not exist rather than sending an unexplained partial package or letting the request go unanswered. Gaps without explanation invite a negative inference.
If Records Are Not in English
You must also provide a certified English translation. Include the translator’s name and address, a brief statement of their qualifications, the translated documents, and copies of the originals.
If You Can’t Meet the Deadline
Contact the FDA representative on the form before the deadline passes. The form explicitly invites you to raise timing concerns. Silence reads as refusal.
What Happens If You Ignore It
The form warns that failing to provide the requested records by the deadline may violate section 301(e) of the FD&C Act (21 U.S.C. § 331(e)), which prohibits refusing to permit access to or copying of records the FDA is entitled to inspect.1U.S. Food and Drug Administration. FDA Records Request (Form 4003) For drug and device manufacturers, there is a second consequence. Your products may be deemed adulterated under section 501(j) of the FD&C Act (21 U.S.C. § 351(j)) on the basis of the failure to cooperate alone.
An adulteration designation can lead to warning letters, import alerts, seizure actions, or injunctions, and it gives the FDA grounds to argue your products should not be on the market until you show compliance. A routine records review can escalate into a full enforcement matter.
One last point worth knowing. Providing records under 374(a)(4) does not prevent the FDA from conducting an on-site inspection anyway.3Office of the Law Revision Counsel. 21 USC 374 – Inspection Responding to Form 4003 is an additional obligation, not a substitute for being inspection-ready.