FDA Customs Broker

A general broker files the CBP entry and pays duty. On FDA-regulated goods, a second filing decides whether the goods can be sold at all: the FDA PGA message set in ACE, with an FDA product code and the affirmation of compliance codes FDA requires for that commodity. Those requirements differ by product. Food lines carry manufacturer and FSVP importer data, drugs carry listing and registration or application numbers, devices carry registration, listing and premarket numbers, and radiation-emitting products carry accession numbers and Form FDA 2877 declarations. FDA's quick reference guide of March 10, 2026 sets which codes are mandatory. The other difference is what happens after filing: an FDA broker has to read the Notice of FDA Action, upload documents to ITACS, track the detention clock, and coordinate the CBP side of any refusal. That is the work this service covers.

FDA does not publish its screening logic, but it names the triggers for manual review: a higher risk score, incomplete data, an apparent import alert match, or targeting for exam or sampling. In practice, holds trace to a short list of causes. A product code that does not match the product or its listing. A missing or invalid affirmation code, such as a device registration that lapsed because the October to December renewal was missed. A foreign firm or product on an import alert. Labeling that fails the rules for that commodity. A drug manufacturer FDA cannot find in its registration database. For food, a missing or late prior notice, or a facility that is not registered, creates a separate hold that cannot be released under bond. We read the notice, identify which cause applies, and tell you what evidence closes it.

May Proceed is FDA's release of a line for entry, either automatically after screening or after review. FDA is explicit that it does not preclude future FDA action: it is not a finding that the product complies. On the CBP side, release of FDA-regulated goods is conditional under 19 CFR 141.113(c). The conditional period ends at the earliest of an FDA refusal, an FDA May Proceed, or 30 days after release, and FDA can extend it by issuing a notice of sampling or detention inside those 30 days. That is why we keep FDA lines open in the Control Tower until the period closes, rather than marking them done at CBP release. If a problem surfaces later, the data, labels and supplier records needed to answer it are already in the entry file.

The FDA ImportShield Program, in effect since August 4, 2025, moved manual entry review from individual ports to a centralized national team. Any entry that does not receive an automated release goes to its reviewers. FDA reports that the 2022 pilot produced 70% faster processing times. Behind it, FDA's SERIO+ platform, with full implementation dated March 2026, brings PREDICT screening and the internal review tools into one system. For importers, the practical effects are that review no longer depends on which port the freight lands at, and that data quality decides more than before, because complete and valid data is what FDA says earns a lower risk score and an automated release. For a broker, the job is to keep lines out of manual review where the data allows it and to answer reviewer requests quickly when they come.

There is no legal time limit. FDA states that no statute or regulation requires it to complete admissibility review within a set time, and that it acts as quickly as possible. What is fixed are the clocks that start once FDA acts. A documents request has no formal deadline, but slow uploads delay review. A detention notice gives 10 business days to respond, usually printed as 20 calendar days. A refusal gives 90 days to export or destroy. For food, a missing prior notice must be filed within 10 calendar days of the refusal notice, and an unregistered facility has 30 days to register. Storage, demurrage and transport during the hold are the importer's cost. We cannot set FDA's pace, but we make sure no delay comes from a missing document or a missed clock on our side.

A Notice of FDA Action marked Detained is the Notice of Detention and Hearing. The legal test is the appearance standard in section 801(a): FDA can refuse an article if it appears, from examination or otherwise, to be adulterated, misbranded, or otherwise in violation. 21 CFR 1.94 gives you the right to present oral or written testimony. The respond-by date is 10 business days, usually shown as 20 calendar days on the notice, and extensions must be requested before that date with a reasonable basis. A response is evidence: registration and listing records, corrected codes, labeling, certificates, or private laboratory analysis. If the violation can be fixed, the path is a reconditioning request instead. With no response, FDA can refuse admission. We draft the response from the entry file and track the date, so an extension, if one is needed, goes in on time.

Form FDA 766 is the importer of record's application to bring detained goods into compliance, by relabeling or other reconditioning, under 21 CFR 1.95. It needs a detailed plan, the time and place of the work, and new labels if relabeling. A bond under section 801(b) is required and must carry a redelivery condition. FDA supervision is billed to the importer at 267% of the GS-11/4 hourly rate for a supervisor or GS-12/4 for an analyst, with a one-hour minimum, plus travel and per diem. A second application needs meaningful changes, and a third is generally not granted. Reconditioning is not available for unapproved new drug charges. Partial release and partial refusal are possible when only part of a lot can be fixed. Radiation-emitting products that fail a standard use the RD declaration codes with an approved Form 766.

A refusal is FDA's final decision, and there is no appeal unless FDA issued it in error. The goods must be exported or destroyed under CBP and FDA supervision within 90 days of the refusal notice, a deadline set by 21 U.S.C. 381(a). FDA says it has no authority to extend it; extension questions go to CBP. FDA may also destroy refused drugs, devices and tobacco products valued at $2,500 or less without an opportunity to export, which mainly affects international mail. If the goods were released under bond, CBP issues a redelivery notice within 30 days of the refusal. We book the export or supervised destruction early, because a refusal handled at day 85 leaves no room for a missed sailing or a carrier that will not accept the cargo.

Under 19 CFR 141.113(c), FDA-regulated goods are released conditionally. If FDA refuses them and CBP demands redelivery, failure to redeliver triggers liquidated damages equal to three times the value of the merchandise, unless the port director required a bond equal to domestic value under 19 CFR 12.3(b). That makes the location of conditionally released goods a financial question, not only a logistics one: product that has been sold, shipped to customers, or commingled in a distribution center cannot be redelivered. We advise holding FDA lines under review in a controlled location until the conditional period ends, and we keep the redelivery timeline visible so a demand never arrives as a surprise.

An import alert tells FDA staff that a firm, product or country has a history that justifies detention without physical examination, or DWPE. Firms and products on an alert's red or yellow list are subject to DWPE, while the green list names firms exempt from it. Once a supplier is on an alert, its shipments are detained until the importer overcomes the appearance of a violation for each one, usually with lab results or documents. Alerts cover whole sectors, from drug and device firms without valid registration or listing to specific food contaminants and radiation-emitting products such as laser pointers. The cheapest time to find an alert is before the purchase order, so we screen your suppliers and product codes against the current lists at onboarding and again whenever you add a new source.

Removal is by petition. FDA's policy sits in Regulatory Procedures Manual section 9-8, and the evidence it expects is concrete: an investigation of the root cause, corrective and preventive actions, and proof that they worked. FDA's own examples include five clean shipments and a third-party audit. Petitions go to ImportAlerts2@fda.hhs.gov unless the specific alert's guidance names another route. Until removal, each shipment still has to overcome the detention on its own evidence, and those cleared shipments become the track record the petition relies on. We assemble the entry history, lab results and supplier documentation into the petition, and keep shipments moving under the alert while it is pending, so the business does not stop while the firm works its way to the green list.

For cosmetics, FDA's quick reference guide of March 10, 2026 still lists the COS code as optional and defines it by the old voluntary registration, even though facility registration and product listing under MoCRA are legal obligations. We transmit a registration number only where FDA accepts it for that firm. Radiation-emitting electronic products subject to a performance standard need the manufacturer's product report accession number, sent as ACC, or ANC for an annual report, plus the Form FDA 2877 declarations sent as RA, RB, RC and RD codes. RD codes cover noncompliant products to be reconditioned under bond with an approved Form 766. Every foreign manufacturer of electronic products must also designate a permanent US resident as agent before offering product for import. Products that are both radiation-emitting and medical devices, such as diagnostic X-ray or medical lasers, carry both data sets.

The importer pays. During an FDA hold, storage, demurrage and transport are for the importer's account, and FDA and CBP state they are not liable for them. Reconditioning adds FDA supervision at 267% of the relevant GS hourly rate with a one-hour minimum, plus the bond and the labor to relabel or rework. A refusal adds export freight or supervised destruction. FDA and CBP publish no average cost of a hold, so any figure you hear is market data, not an official number. What controls the bill is time: every day a line waits for documents, a response, or a decision adds storage and demurrage. Our hold response work is quoted separately from standard entry fees, so the cost of a detention is visible on its own rather than buried in the brokerage invoice.

Send your product list with FDA product codes if you have them, HTS classifications, countries of origin, and the commodity type of each line: food, dietary supplement, cosmetic, drug, device, or radiation-emitting product. Add the foreign manufacturers and shippers with their FDA registration numbers, and for food, the FSVP importer and its DUNS number. Tell us your ports, modes and monthly entry volume, and share any open holds, recent Notices of FDA Action, or suppliers you know are on an import alert. With that we map the codes per line, screen suppliers, and quote entry filing and hold response separately. Device importers that also carry initial importer duties can run both through the same entry file, so registration, listing and entry data are checked against each other.