The FDA Warning Letter With No Inspection: Section 704(a)(4) Records Requests

An FDA warning letter used to arrive after an inspector had walked your floor, opened your batch records and written up what they found. For a growing number of foreign manufacturers, that is no longer how it works. FDA can now build and issue a full warning letter without ever setting foot in your facility. It does this using a records request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. In 2026 a steady stream of these letters has gone to over-the-counter drug makers in Europe, Asia and South America, and every one of them started with an email, not a site visit.

For any company that exports drugs to the United States, this changes the risk calculus. You can no longer assume that distance, a full inspection calendar or the absence of a scheduled audit protects you. If FDA has your registration on file, it can ask for your records, review them remotely, and act on what it sees or on your silence. This guide explains what a 704(a)(4) records request is, why FDA is leaning on it, what the 2026 letters reveal, and how to be ready before one lands in your inbox.

Executive summary

• What it is: A records request under section 704(a)(4) of the FD&C Act, allowing FDA a remote compliance review without a site visit.
• Why it matters: FDA can find CGMP failures, deem your drugs adulterated under section 501(a)(2)(B), and issue a warning letter without inspecting you.
• Who is exposed: Any facility registered with FDA as a drug manufacturer, especially foreign OTC drug makers exporting to the United States.
• The trap of silence: Ignoring the request is a prohibited act under section 301(e), and it can lead to import refusal and detention without physical examination.
• The 2026 pattern: Letters have cited missing identity testing, absent stability studies, unvalidated processes and incomplete laboratory records, all read from the documents companies submitted.
• What to do: Treat your records as inspection-ready at all times, keep a monitored regulatory contact email, and close CGMP documentation gaps now.

What is a section 704(a)(4) records request?

A section 704(a)(4) records request is a formal FDA demand for records and other information about how you manufacture, process, pack or hold your drug products. Congress gave FDA this power so the agency could assess a facility remotely, in advance of or in lieu of a physical inspection. In plain terms, FDA emails a request to the contact on your registration file, you send back documents, and FDA evaluates whether your operation conforms to current good manufacturing practice from those documents alone.

The legal reasoning is direct. Under section 501(a)(2)(B) of the FD&C Act, a drug is adulterated if the methods, facilities or controls used to make it do not conform to CGMP. FDA does not need to see a defect in the finished product. It only needs to conclude, from your records, that your controls do not meet the standard. That conclusion supports a warning letter and, if left unresolved, refusal of your products at the border.

Why FDA is using records requests now

The tool solves a practical problem. FDA cannot physically inspect every foreign site that ships drugs to the United States, and travel to inspect a small OTC manufacturer can take days and significant cost. A records request lets the agency identify facilities with weak CGMP systems without leaving the office, and concentrate scarce inspection resources on the highest risk sites. The approach began with a wave of letters to foreign OTC manufacturers several years ago and has become a routine enforcement channel in 2026.

For manufacturers, the significance is that the threshold for enforcement has dropped. A facility that has never been inspected, and might not be for years, can still receive a warning letter within months of a records request. Every registered foreign OTC and drug site is now exposed, whether or not an inspection is ever scheduled.

What the 2026 warning letters reveal

Two letters from 2026 show the two ways a records request turns into a warning letter: a weak response and no response at all. Both sit alongside the broader run of FDA warning letters citing data integrity that has defined 2026 enforcement.

The Respilon letter is a clean teaching case. Everything FDA cited came from the documents the company itself submitted. There was no inspection, no Form 483 and no site walk. The firm records showed that it did not perform identity testing on each incoming component, had not carried out stability studies to support the expiry dates it printed, had not validated its manufacturing process, had not validated its test methods, and could not produce a complete assay result on its certificate of analysis. FDA recommended the firm engage a qualified CGMP consultant under 21 CFR 211.34.

The Aeroflex letter shows the other path. The company simply did not reply. FDA reminded it that refusing to permit access to or copying of records required under section 704(a) is a prohibited act under section 301(e) of the FD&C Act. With no records to review, FDA had no indication of the level of quality assurance at the site, and warned that its products could be detained or refused admission under section 801(a)(3). Silence did not avoid the problem. It became the problem.

These two are not isolated. Through 2026 FDA issued similar letters to OTC drug makers in several countries, citing weak component testing, missing stability data and unvalidated methods, all drawn from records rather than inspections.

What FDA looks for in your records

The CGMP expectations FDA tests through a records request are the same fundamentals it would examine in person, and the same ones that make audit trail and data integrity review so important. The most commonly cited areas in the 2026 letters are:

• Component identity testing. Each incoming component tested to verify identity, with supplier test analyses validated (21 CFR 211.84).
• Stability program. Data that support every expiry date you print (21 CFR 211.166(a)).
• Process validation. Evidence your process is reproducible and controlled (21 CFR 211.100(a)).
• Method validation. Documented accuracy, specificity, precision and reproducibility of your test methods (21 CFR 211.165(e)).
• Laboratory records. Complete data, including individual assay results, not just a PASS statement (21 CFR 211.194(a)).
• Microbiological control. A risk-based justification for any reduced or omitted microbial testing.

Which companies are most at risk

The clearest targets are foreign facilities registered with FDA as OTC drug manufacturers, because the agency cannot inspect them all in person. The 2026 letters went to sites in the Czech Republic, Brazil and elsewhere. The same exposure reaches contract manufacturers, private-label makers and any registered drug site that has never scheduled an inspection. Exporters who also ship dietary supplements should note that a parallel records-based scrutiny applies under 21 CFR Part 111, so a single site can face records demands across more than one FDA programme.

Records-request readiness checklist

Use this checklist to prepare for a section 704(a)(4) records request before one arrives.

• Confirm the contact email on your FDA registration is monitored daily and routes to a named regulatory owner.
• Keep component identity test records for every incoming lot, with supplier qualification and certificates of analysis.
• Hold current stability data supporting every labelled expiry date.
• Maintain process validation reports demonstrating a reproducible, controlled process.
• Maintain analytical method validation or verification for every assay you run.
• Ensure laboratory records show complete data and individual results, not a bare PASS.
• Document a microbial risk assessment justifying your testing approach.
• Prepare an English-language records package you can send within the response window.
• Assign an owner and a 15 working day response plan for any records request.
• Run a mock records request to test whether you could actually produce the documents on demand.

Common mistakes to avoid

• Assuming no inspection means no enforcement. A records request needs no site visit.
• Letting the registration contact email go unmonitored, so the request and its follow-ups are missed.
• Ignoring the request in the hope it goes away. Non-response is a prohibited act under section 301(e).
• Sending a certificate of analysis that states PASS without the underlying test results.
• Printing expiry dates with no stability data to support them.
• Relying on a supplier certificate without identity testing each incoming component.
• Treating process and method validation as optional for small OTC products.
• Missing the 15 working day response deadline without asking for more time.

Frequently asked questions

Can FDA issue a warning letter without inspecting my facility?

Yes. Under section 704(a)(4) of the FD&C Act, FDA can request your records, review them remotely, and issue a warning letter based on what those records show, with no on-site inspection and no Form 483.

What is a section 704(a)(4) records request?

It is a formal FDA request for records and other information about how you manufacture your drugs, made in advance of or in place of a physical inspection. FDA typically sends it by email to the contact on your registration file.

What happens if I ignore the records request?

Refusing to permit access to or copying of the requested records is a prohibited act under section 301(e) of the FD&C Act. FDA can conclude it has no evidence of your quality assurance, issue a warning letter, and move to refuse your products at the border under section 801(a)(3).

Which companies are most at risk?

Foreign facilities registered with FDA as OTC drug manufacturers are the main focus, because FDA cannot inspect them all in person. Any registered drug site exporting to the United States can receive a request.

How long do I have to respond to a warning letter?

FDA asks for a written response within 15 working days of receiving the letter, describing what you have done to correct the violations and prevent recurrence. If you cannot finish in that time, state your reasons and a schedule for completion.

How can we prepare for a records request?

Keep your CGMP records inspection-ready at all times, monitor the registration contact email, hold identity testing, stability, process validation and method validation records, and run a mock records request to confirm you could produce the documents quickly.

How MFLRC can help

A records request is won or lost long before it arrives, in the quality of the documents you already hold. MFLRC helps foreign OTC and drug manufacturers, and their importers, build records that stand up to remote review, the same discipline that underpins strong supplier and contract manufacturer oversight.

Our support includes:

• Records-request readiness reviews and mock 704(a)(4) exercises against your actual documents.
• CGMP gap assessments covering identity testing, stability, process validation and method validation.
• SOP development, data integrity remediation and CAPA support for the gaps the review finds.
• Warning letter and Form 483 response drafting, with a defensible corrective and preventive action plan.
• Import and export compliance support, including Import Alert 66-40 and detention without physical examination.

Our audit services, quality assurance support and regulatory affairs and import and export practice turn a records request from a threat into a routine exercise. If you want to measure where you stand today, start with our inspection-readiness self-assessment.

Conclusion

The section 704(a)(4) records request has quietly changed what enforcement looks like for foreign drug makers. There is no inspector in the corridor and no advance notice of a site visit, only an email and a deadline. The Respilon and Aeroflex letters show that both a weak response and no response lead to the same place: an adulteration finding and the risk of losing access to the United States market. The defence is not clever argument after the fact. It is having identity testing, stability, process validation and complete laboratory records already in place, and a monitored inbox to receive the request. The companies that treat every day as records-ready will never be surprised by the email that used to be an inspection.

Sources and references

• FDA, Warning Letter to Respilon Production S.R.O., MARCS-CMS 719705, 20 April 2026.
• FDA, Warning Letter to Aeroflex Industria de Aerosol Ltda., MARCS-CMS 728186, 22 May 2026.
• FDA, Warning Letters database, Office of Compliance.
• Federal Food, Drug, and Cosmetic Act, section 704(a)(4) (21 U.S.C. 374(a)(4)), section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), section 301(e) (21 U.S.C. 331(e)) and section 801(a)(3) (21 U.S.C. 381(a)(3)).