When goods answer to more than one agency
Food, beverages, supplements, cosmetics, devices, OTC products, pet food and ingredients carry a second data set and a second decision. Both are handled inside the customs entry rather than bolted on after it.
A specialism within customs brokerage — not a separate business. Most of what we file is ordinary commercial cargo.
Where FDA reviews an imported product, the customs entry carries additional data — product codes, manufacturer and registration details, affirmations of compliance, Prior Notice for food, and the FSVP importer where required. CBP releases the customs entry; FDA decides admissibility separately. An entry can satisfy one and stall on the other.
Key takeaways
- Two agencies, two decisions — cargo moves when both allow it.
- The FDA data set must be correct at transmission, not corrected afterwards.
- Product codes are more specific than tariff codes and are a common cause of holds.
- Most avoidable problems are visible in the paperwork before the cargo sails.
- Government timelines for review, examination and analysis cannot be promised by anyone.
Before the cargo moves
FDA Import Entry Support
The whole FDA side of an entry: product codes, affirmations, registration data and Prior Notice, prepared with the customs declaration rather than after it.
FDA Prior Notice
Who files it, when it is due, and confirming in writing that it was actually submitted before the shipment departs.
FSVP Entry Coordination
Identifying the FSVP importer and carrying that information correctly into the entry.
FDA Product Code Review
Matching the product code and affirmations of compliance to what is actually in the container.
Registration Verification
Checking that facility registration is current and matches the shipment, before transmission rather than after a hold.
Entry Review
A pre-arrival check of classification, documents and agency data while problems are still cheap to fix.
Document Request Help
Working out precisely what has been asked for, and submitting it complete the first time.
FDA Examination Coordination
Exam site arrangements, cargo access, movement and storage exposure through to a release decision.
FDA Sampling Coordination
Cargo access, sample collection, laboratory timing and the storage exposure while results are pending.
FDA Detention Coordination
Reading the notice, understanding what is required, and working the response within the period.
Notice of FDA Action
Which notice you have received, what it actually says, and what response it requires.
Refusal & Re-Export
When admission is refused: the options, the deadlines, and coordinating what follows.
Entry Compliance Review
A look back across your regulated entries to find the pattern behind repeated holds.
Holds & Detentions
Cargo held by CBP or a partner agency — reading the notice and coordinating the response.
Retro Customs Brokers is an independent customs brokerage and is not affiliated with or endorsed by the U.S. Food and Drug Administration, U.S. Customs and Border Protection, or any other government agency. FDA and CBP retain sole authority over entry, examination, sampling, release, detention, refusal and admissibility decisions. Where an import matter requires specialised FDA regulatory support outside customs brokerage, additional assistance can be coordinated through affiliated service providers.
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start. If the cargo has already landed, call rather than email.