FDA — Import Program
FDA's own information for the import trade: how imported products are regulated, screened, and reviewed, and what importers are expected to do.
fda.gov/industryImporter Resources
FDA Detention Resources for Importers
Practical reference material for anyone facing an FDA import detention: what to do in the first 24 hours, which documents to gather, a plain-language glossary of the terms on your notice, and where the official government information lives.
Quick Start
The First 24 Hours After an FDA Notice of Action
The first day sets the pace of the whole case. Four moves, in order:
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Read the Notice Properly
Note three things: the charge (the suspected violation), the entry and line numbers, and the response deadline. The charge determines what evidence you need; the deadline determines how fast.
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Locate the Cargo
Confirm exactly which facility holds the shipment and get a direct contact there. Facility authorization is the most common schedule bottleneck — solving it early is the biggest accelerator you control.
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Alert Your Team
Your customs broker first, and your regulatory consultant or attorney if you use one. They handle the entry and the strategy; evidence coordination plugs in underneath.
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Start the Evidence Clock
If laboratory testing may be part of the response, begin the same day — it's the piece with the longest lead time. Send everything you have, even if incomplete.
Gather These
Document Checklist for a Sampling Case
Everything on this list speeds up your case; nothing on it is a reason to delay your first message. Send what you have — missing items get flagged at intake.
- FDA Notice of Action — the notice itself, all pages
- Entry number — and affected line numbers
- Product details — name, category, and description
- Labels — photos or files of product labeling
- Lot / batch numbers — and quantities per lot
- Shipment location — the facility holding the cargo
- Warehouse contact — name, phone, email at the facility
- Broker contact — your customs broker's details
- Import alert number — if the notice cites one
- Temperature condition — ambient, refrigerated, or frozen
- Advisor contact — consultant or attorney, if engaged
- Prior test reports — any existing analyses, if available
Plain Language
Glossary of FDA Detention Terms
The vocabulary on your notice and in this process, defined without jargon. Twenty-two terms importers actually encounter.
- FDA Import Detention
- A hold placed on an imported shipment when FDA has reason to believe the product may violate the laws it administers. The importer gets an opportunity to respond with evidence before FDA decides admissibility.
- Notice of Action
- The official FDA document announcing an action on an import entry — for a detention, it states the charge, the affected entry lines, and the response deadline.
- Charge
- The specific suspected violation stated on the notice (for example, adulteration due to Salmonella). The charge defines what the response evidence must address.
- Refusal
- The outcome when a detention is not successfully answered: the entry is denied admission, and the goods must generally be exported or destroyed under the applicable procedures.
- Entry Number
- The unique identifier assigned to an import entry in the customs process — the reference every party uses to identify the shipment.
- Entry Line
- A single product listing within an entry. FDA acts at the line level, so some lines on an entry can be detained while others proceed.
- Import Alert
- A published FDA instruction allowing detention of covered future shipments without physical examination. Alerts list the products, firms, or regions covered and the charge they carry.
- DWPE
- Detention Without Physical Examination — the mechanism of an import alert. Covered shipments are presumed violative on arrival, shifting the evidentiary burden to the importer.
- Red List
- The portion of an import alert naming the firms, products, or regions subject to DWPE under that alert.
- Green List
- On alerts that maintain one, the list of firms or products exempted from DWPE after FDA is satisfied the compliance concern is resolved.
- Petition for Removal
- A formal request to FDA to remove a firm or product from an import alert, supported by evidence — commonly a documented history of non-violative shipments and correction of the root cause.
- Private Laboratory Analysis
- Testing of the detained product by an independent, non-government laboratory at the importer's initiative, used as evidence in the detention response.
- Chain of Custody
- The documented, unbroken record of a sample from collection to laboratory receipt — who handled it, when, and in what condition — proving the tested sample came from the detained shipment.
- Representative Sample
- A sample drawn under a plan that fairly reflects the whole detained lot — accounting for lot structure, packaging, and the testing method — rather than a convenient grab.
- Sampling Plan
- The documented approach for a collection: which lots, how many units, from where, in what quantities, with what identification, sealing, and handling.
- Tamper-Evident Seal
- A uniquely numbered closure that cannot be opened without visibly breaking. Recorded at collection and verified at laboratory receipt, it documents that the sample was not accessed in transit.
- LAAF
- FDA's Laboratory Accreditation for Analyses of Foods program. For certain food testing — including some testing supporting admission of detained food — FDA may require a LAAF-accredited laboratory.
- ISO/IEC 17025
- The international standard for the competence of testing laboratories. Accredited labs carry a defined scope listing the methods they are accredited to perform.
- Validated Method
- An analytical procedure whose reliability has been demonstrated for the specific analyte and product type — the difference between a result that carries weight and one that invites challenge.
- Certificate of Analysis (COA)
- A document describing testing performed on a product, typically by or for the supplier. A supplier's COA generally cannot substitute for analysis of the detained lot itself under documented custody.
- Reconditioning
- A separate pathway in which an importer may request FDA authorization to bring a non-compliant shipment into compliance — for example, by relabeling or reprocessing — under an approved plan.
- Bonded Warehouse / CFS
- Facilities where imported goods can be held under customs control — bonded warehouses and container freight stations. Each has its own access and supervision rules that sampling must respect.
Primary Sources
Official Government Resources
For regulatory questions, go to the source. These are official U.S. government websites — independent of this company, linked for your reference.
FDA — Import Alerts
The published import alerts themselves, searchable by number, product, country, and firm — the authoritative text on who and what each alert covers.
accessdata.fda.gov import alertsU.S. Customs & Border Protection
CBP's resources on the entry process, bonded facilities, and customs requirements — the other half of the import picture alongside FDA.
cbp.govThese links go to official U.S. government websites operated independently of FDA Detention Sampling. For information about the LAAF program, search "LAAF" on FDA.gov — the agency's pages are the authoritative source on accreditation requirements.
Go Deeper
Detailed Guides on This Site
How the Process Works
The five stages of a sampling case — what happens, who's involved, and where time is won or lost.
Read the guideChain of Custody
Representative sampling, sealing, the anatomy of a custody record, and the failures that break it.
Read the guideLaboratory Testing
How labs are matched to your charge, what LAAF means, and what reports include.
Read the guideImport Alert Support
DWPE explained, the two evidence tracks, and what removal actually requires.
Read the guideProducts & Industries
Twelve categories with their common detention reasons and typical testing.
Read the guideService Areas
Fourteen major import markets, eight facility types, and how nationwide coordination works.
Read the guideAll Services
The complete list of sixteen coordination services, with scope and honest limits.
Read the guide150 FAQs
Twenty-five direct answers per topic across detentions, sampling, testing, alerts, costs, and the company.
Browse the FAQsAbout the Company
Who we are, what we do and don't do, and the principles behind every case.
Read the guideBeyond Reference Material
When You're Ready, Bring Us the Actual Case
Reference pages answer general questions; your detention is specific. Send the FDA Notice of Action, product details, and shipment location for an honest, case-specific read.
Urgent detention matters receive priority intake review.
FDA Detention Sampling is an independent private company. We are not affiliated with, endorsed by, or part of the U.S. Food and Drug Administration. Material on this page is general information, not legal or regulatory advice; definitions are plain-language summaries, and the official government sources linked above are authoritative. Sampling, laboratory testing, documentation, and coordination services do not guarantee FDA release, admissibility, acceptance of laboratory results, or any specific regulatory outcome. FDA makes the final admissibility decision.