FDA Unannounced Inspections of Foreign Facilities: What FSMA Changed and How to Prepare

Before the Food Safety Modernization Act of 2011, the FDA had limited practical authority over foreign food facilities. Most overseas inspections required extensive advance coordination, and the agency depended heavily on foreign regulatory counterparts for compliance oversight of facilities outside US jurisdiction. Section 307 of FSMA changed the operational reality. The law gave the FDA explicit authority to deny entry to food from any foreign facility that refuses or delays an FDA inspection — creating the first enforceable market access lever the agency had against non-cooperative foreign facilities. FDARA (FDA Safety and Landmark Advancements Act) in 2022 reinforced and expanded this authority. Unannounced inspections of foreign food facilities are now a genuine operational risk for any facility that exports to the United States.

What FSMA Section 307 requires

Section 307 of FSMA amended the FD&C Act to make foreign facility inspection a condition of importing food into the United States. Foreign food facilities registered with the FDA must permit the FDA to inspect the facility at a time and in a manner permitting the FDA to determine whether the food manufactured, processed, packed, or held at the facility meets the requirements of the FD&C Act. Critically, the FDA is not required to announce an inspection in advance. If a foreign facility refuses inspection, delays access, or fails to make records available during an inspection, the FDA can administratively refuse entry to food from that facility — without a court order and without a separate enforcement proceeding. The facility's products remain blocked until the FDA determines that the non-cooperation issue has been resolved and a satisfactory inspection has occurred.

How the FDA selects foreign facilities for inspection

The FDA uses a risk-based system to prioritize foreign inspections, focusing on facilities with prior compliance findings, product categories with elevated contamination risk, countries with weaker food safety infrastructure, and facilities flagged through FSVP audit reports, import sampling failures, or outbreak investigations. Facilities that have appeared on Import Alerts, had shipments refused at US ports, or been reported by US importers following FSVP supplier audits face higher inspection probability. FSMA mandated that the FDA conduct a specified number of foreign inspections per year, with inspection counts increasing over the first years of the law's implementation. The agency has concentrated this inspection capacity on the highest-risk categories — seafood, produce, infant formula, spices, and dietary supplements.

What to have ready before an unannounced inspector arrives

The facility registration must be current: the FDA inspector will verify registration details against what they observe, and discrepancies are an automatic finding. The US Agent's contact information must be readily available and the US Agent must actually be reachable — the inspector may attempt contact before entering the facility. The food safety plan must exist and be accessible in the facility: under 21 CFR Part 117, human food manufacturers must maintain a written food safety plan including hazard analysis, preventive controls, monitoring procedures, corrective action records, verification activities, and a supply chain program. Records must be in a format legible to the inspector, with English-language versions available. Seafood facilities must have their HACCP plan, and low-acid canned food producers must have their scheduled process documentation on hand.

What happens after an unannounced inspection

Observations made during the inspection are recorded on FDA Form 483, a written list of objectionable conditions. The facility has 15 business days to respond to the Form 483 with a corrective action plan that addresses each observation specifically. If the FDA determines violations are serious, it issues a Warning Letter — a formal public document naming the facility, describing the violations, and requiring specific corrective actions. Warning Letters are published on the FDA's website and are searchable by buyers, importers, and media organizations. A facility that cannot address Warning Letter violations satisfactorily faces escalating enforcement: Import Alert, injunction, or seizure. The most effective way to manage an FDA inspection is to have nothing to find — which requires preparing the facility as if an inspector could arrive on any given day.

How FDABridge helps foreign food facilities prepare

FDABridge reviews foreign food facility compliance readiness, identifies gaps in food safety plan documentation, registration accuracy, and recordkeeping practices, and advises on corrective action before an inspection occurs. We also provide US Agent services that keep the FDA-to-facility communication channel open and responsive at all times. Visit fdabridge.com/food for our food registration and compliance services, or fdabridge.com/contact to discuss your facility's preparation.