FDA compliance for food and beverage exporters.

The framework

• Food facility registration and biennial renewal, for facilities that manufacture, process, pack or hold food for consumption in the United States.
• Preventive controls under 21 CFR 117: a written food safety plan with hazard analysis, preventive controls, monitoring, corrective actions and verification, prepared or overseen by a preventive controls qualified individual.
• Seafood HACCP under 21 CFR 123 and juice HACCP under 21 CFR 120 — separate regimes with their own plans and records.
• Acidified and low-acid canned foods under 21 CFR 108, 113, 114, including process filing and a scheduled process from a competent authority.
• Labeling under 21 CFR 101: identity, net quantity, ingredient list, allergen declaration and the nutrition facts format.
• Your importer's obligations under the Foreign Supplier Verification Programs rule — legally theirs, but supportable only with documents that come from you.

Where entries actually fail

Most refusals are not exotic. Pesticide residues above tolerance, or with no tolerance established for that commodity. Salmonella in low-moisture products. Undeclared allergens, most often milk, soy, sesame or a colour. Nutrition panels using the wrong serving size or an outdated format. A missing process filing for an acidified product. Each of these has a corresponding import alert behind it.

What we do

• Gap analysis against the part that actually applies to your product.
• Writing or repairing the food safety plan, with the hazard analysis that supports it.
• Label and artwork review before it goes to print, not after the entry is detained.
• Residue and pathogen testing strategy, and coordination with the laboratory.
• Supplier and grower controls at origin, where most residue problems begin.
• Import alert removal work where the product is already listed.

Common questions

Do we need a United States agent?

Every foreign facility registering with FDA has to name a United States agent for communications. The agent is a point of contact, not a compliance function — naming one does not make the facility compliant. We do not act as a United States agent; that role requires a physical address in the United States.

Our buyer handles FSVP. Does that cover us?

FSVP is the importer's legal obligation, so in that narrow sense yes. In practice the importer can only verify what you can document, and a supplier who cannot produce hazard analyses, test results and corrective action records is eventually replaced.

Is a private certification such as BRC, FSSC or GlobalG.A.P. enough for FDA?

No. These schemes overlap heavily with FDA requirements and are useful evidence, but FDA enforces its own regulations. Certification does not substitute for a food safety plan that meets 21 CFR 117.

We have never shipped to the United States. Where do we start?

Registration, then a hazard analysis against 21 CFR 117 — or 123 or 120 if those apply — then labeling. Leaving labeling until last is the most common and most expensive sequencing error.