Next Steps After FDA Food Facility Registration Approval

Once your FDA food facility registration is approved, you must verify the registration confirmation and ensure all details are accurate. The FDA issues a registration number, which you must include on all import documentation and shipping records. You should also confirm that your registration is listed in the FDA's public database, as this is a requirement for US Customs and Border Protection (CBP) clearance.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 415, all facilities that manufacture, process, pack, or hold food for consumption in the United States must register with the FDA. Registration is valid for two years, and you must renew it between October 1 and December 31 of each even-numbered year. Failure to renew will result in automatic cancellation, and your products will be refused entry at US ports.

You should also designate a US Agent (if you are a foreign facility) and ensure their contact information is current. The US Agent serves as the FDA's point of contact for communication and must be physically present in the United States. If your US Agent changes, you must update the registration within 30 days.

Yes, registration alone does not satisfy all FDA requirements. The Food Safety Modernization Act (FSMA) mandates that most food facilities implement a written food safety plan based on Hazard Analysis and Risk-Based Preventive Controls (HARPC). This plan must identify potential hazards (biological, chemical, physical, and radiological) and specify preventive controls to minimize or prevent them.

The FSMA Preventive Controls for Human Food rule (21 CFR Part 117) requires facilities to conduct a hazard analysis, establish preventive controls, monitor their effectiveness, take corrective actions when needed, and verify that the system is working. You must also maintain records of these activities for at least two years. Facilities that only handle raw agricultural commodities or are subject to FDA's juice or seafood HACCP regulations may be exempt from certain requirements.

If you are a small business or a very small business, you may qualify for modified requirements or extended compliance dates. However, you must still register and comply with basic CGMP (Current Good Manufacturing Practice) requirements under 21 CFR Part 117 Subpart B. Consult the FDA's guidance on FSMA exemptions to determine your specific obligations.

Every shipment of food imported into the United States requires prior notice to the FDA. Under the Bioterrorism Act and FSMA, you must submit prior notice electronically through the FDA's Prior Notice System Interface (PNSI) or the Automated Broker Interface (ABI) at least 2 hours before arrival by land, 4 hours before arrival by air or rail, and 8 hours before arrival by vessel.

The prior notice must include your FDA registration number, the product's FDA product code, the manufacturer's details, the shipper and consignee information, and the anticipated arrival date and port. If the prior notice is incomplete or inaccurate, CBP may hold the shipment for inspection or refuse entry entirely. You should coordinate with your US importer or customs broker to ensure timely and accurate submission.

Note that prior notice is required for each individual shipment, even if you have an active registration. There is no blanket exemption for registered facilities. Failure to submit prior notice can result in detention, refusal of admission, or civil penalties.

You must maintain records that demonstrate compliance with FDA regulations, including registration renewal, FSMA preventive controls, and prior notice submissions. The FDA requires that records be kept for at least two years from the date of creation, unless a specific regulation requires a longer period (e.g., records for infant formula must be kept for three years).

Key records include: your food safety plan (including hazard analysis, preventive controls, monitoring, corrective actions, and verification), supplier verification records (if you receive ingredients from other facilities), training records for personnel handling food, and shipping and receiving records. All records must be in English or accompanied by an accurate English translation.

The FDA has the authority to inspect your facility and request these records during an inspection. If you are a foreign facility, the FDA may request records remotely or through your US Agent. Failure to maintain or provide records can result in warning letters, import alerts, or suspension of your registration.

If your FDA food facility registration expires (due to non-renewal) or is suspended by the FDA, you cannot legally export food to the United States. The FDA may suspend a registration if it determines that food from the facility poses a reasonable probability of serious adverse health consequences or death to humans or animals.

In case of suspension, the FDA will issue a notice stating the reasons and provide an opportunity for an informal hearing. You must take corrective actions to address the violations and submit a written request for reinstatement. The FDA will inspect the facility (or review evidence) before lifting the suspension. During suspension, any food already in the US may be subject to detention or recall.

To avoid suspension, ensure your facility complies with all applicable FDA regulations, including CGMPs, preventive controls, and recordkeeping. Regularly review FDA import alerts and warning letters to identify common compliance issues. If you receive a Form 483 (inspection observations) or a warning letter, respond promptly and address all cited deficiencies.

Review your FDA registration confirmation and ensure your US Agent details are current. If you have not yet implemented a FSMA-compliant food safety plan, begin the hazard analysis process immediately. For specific compliance questions, consult a qualified regulatory consultant or attorney experienced in FDA food law.

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This page provides preliminary information. It is not legal advice. For your matter, consult a qualified professional.