What Happens When a Foreign Food Facility Falls Out of FSMA Compliance

The Food Safety Modernization Act created a continuous compliance obligation for every foreign food facility that registers with FDA. Registration is not a certificate earned once and filed away — it must be renewed in every even-numbered year, and the facility's operations must remain consistent with FDA requirements at all times. When a foreign facility falls out of compliance — through an expired registration, a failed inspection, an import alert, or a documented hazard analysis failure — the consequences affect its ability to export to the United States and its relationship with US importers.

What causes a foreign facility to fall out of FSMA compliance

The most common cause is a lapsed registration. FDA food facility registrations must be renewed between October 1 and December 31 of every even-numbered year (2024, 2026, 2028, and so on). A facility that misses the renewal window does not simply have an outdated registration — it is legally unregistered, and any food it ships to the United States may be refused entry. Inspections are a second trigger. FDA has authority under FSMA Section 301 to inspect foreign registered facilities. If an inspection reveals a significant violation — adulteration, misbranding, failure to maintain a food safety plan, or failure to implement preventive controls — FDA can initiate a range of enforcement actions starting with a Form 483 and escalating to a Warning Letter or Import Alert. A third trigger is importer-side pressure. US importers operating under the Foreign Supplier Verification Program (FSVP) must conduct ongoing verification of their foreign suppliers. If a supplier cannot provide audit results, food safety plan documentation, or corrective action records, the importer may suspend purchasing to protect its own FSVP compliance.

The Import Alert mechanism

Import Alert 99-35 is FDA's primary tool for blocking shipments from registered facilities that have been found to pose a safety risk or that have refused an inspection. Once a facility is placed on an import alert, its products are subject to detention without physical examination (DWPE) at the US border. Customs and Border Protection will hold each shipment, and the importer must request a hearing or provide evidence of corrective action before any lot is released. Being on an import alert does not automatically result in registration cancellation, but it effectively shuts down US exports until the underlying violation is resolved. Removal from an import alert requires submitting evidence of corrective action to FDA and typically involves a follow-up inspection or a third-party audit.

How to recover from a lapsed registration

If a facility's FDA registration has lapsed because it missed the biennial renewal window, the correct step is to re-register through the FDA Unified Registration and Listing System (FURLS). This is a new registration, not a renewal. The facility will receive a new registration number and will need to update any US importers or US Agent relationships that reference the previous registration. The facility must also ensure that its US Agent — required for all foreign registrants — is in place and has accurate contact information before the new registration is submitted. Attempting to ship food to the US on an expired registration creates a legal violation separate from the underlying food safety issue.

What to do after an inspection observation or Warning Letter

After an FDA Form 483 is issued — the list of observations an investigator writes at the end of an inspection — the facility typically has 15 business days to submit a written response. This response should document the root cause of each observation and describe the corrective action taken or planned, with supporting evidence. If FDA subsequently issues a Warning Letter, the response timeline is usually 15 calendar days and the response must be more comprehensive. Failure to respond adequately results in escalation: referral to FDA's Office of Criminal Investigations, import alerts, injunctions, or referral to the US Department of Justice. FDABridge assists foreign manufacturers in preparing inspection responses and building the documentation required to demonstrate compliance.

Prevention is less expensive than recovery

The cost of resolving an FSMA compliance failure — legal fees, corrective action implementation, third-party audits, product recalls, and lost commercial relationships — typically far exceeds the cost of maintaining compliance in the first place. The fundamentals are: maintain an active FDA registration, update your US Agent contact information whenever it changes, keep a written food safety plan current and accessible, conduct annual internal audits, and track the biennial renewal window. FDABridge offers food facility registration services, US Agent services, and compliance documentation review. Visit fdabridge.com/food for details or fdabridge.com/contact to discuss your facility.