U.S. FDA Food Facility Registration: Export Compliance Review
U.S. FDA food facility registration should be reviewed around the facility and food categories, not reduced to a single registration number. Facilities that manufacture, process, pack, or hold food for consumption in the United States generally need a registration review. Foreign facilities should also confirm that U.S. Agent, facility role, food categories, and renewal status match the actual export records.
Pre-Export Checklist
| Item | Review focus | Common risk |
|---|---|---|
| Facility applicability | Confirm whether the business manufactures, processes, packs, or holds food for U.S. consumption | The trading entity is checked while the actual manufacturing or holding facility is missed |
| U.S. Agent | Review U.S. Agent information and communication responsibility for a foreign facility | Agent details are outdated or inconsistent with registration and import records |
| Biennial renewal | Confirm renewal during the October 1 to December 31 window in each even-numbered year | An old registration was not renewed, creating abnormal import-record status |
| Food categories and labeling | Review food categories, ingredients, allergens, nutrition facts, and claim boundaries | Registration category, label, and exported SKU do not match |
| Special food pathways | Assess FCE/SID records separately for acidified foods and low-acid canned foods | Standard facility registration is treated as covering all food-process requirements |
Wording Boundaries
- Do not present food facility registration as FDA endorsement of product quality, formula, or function.
- After facility, brand, contract manufacturing, or food-category changes, review registration and labeling records again.
- Importer, factory, warehouse, and brand-owner information should stay consistent across registration, invoices, labels, and import records.
- Infant foods, dietary supplements, acidified foods, low-acid canned foods, and other special categories should be reviewed separately.
Green Ark's Recommendation
Green Ark (Shenzhen) Certification Co., Ltd. recommends building a review table that links facility role, U.S. Agent, food category, renewal status, label files, and import records. This reduces compliance risk caused by mismatches between registration data, label information, and actual exported SKUs.
