🚢 Module 13 of 17 — Operations
Import Process
A–Z
Every product regulated by FDA must pass through the import admissibility process before it can enter U.S. commerce. This module covers the complete import workflow from the moment a shipment leaves the foreign facility to the moment it clears — or doesn't. CBP entry, PREDICT risk screening, the detention process, notices of refusal, import alerts, the hearing process, how to get products off import alert, and the complete pre-shipment compliance checklist that prevents problems before they happen.
Two Agencies, One Border — FDA and CBP
Every product crossing the U.S. border involves two federal agencies with overlapping but distinct roles. Understanding which agency controls which part of the process is essential for advising clients on import strategy.
🛃
CBP — U.S. Customs and Border Protection
Controls: Physical entry of goods, tariff classification, duty collection, import admissibility coordination. CBP processes all import entries through ACE (Automated Commercial Environment) — the single electronic system for all trade.
CBP's FDA role: Transmits import entry data to FDA's PREDICT system. Holds shipments flagged by FDA. Refuses entry of FDA-refused shipments. Issues Notices of Detention on FDA's behalf.
CBP does not evaluate FDA compliance — they enforce FDA's detention and refusal decisions.
CBP's FDA role: Transmits import entry data to FDA's PREDICT system. Holds shipments flagged by FDA. Refuses entry of FDA-refused shipments. Issues Notices of Detention on FDA's behalf.
CBP does not evaluate FDA compliance — they enforce FDA's detention and refusal decisions.
🏛️
FDA — Office of Regulatory Affairs (ORA)
Controls: FDA compliance screening of all regulated products. Prior Notice review (food). PREDICT risk scoring. Physical examination and sampling. Issuance of Notices of Detention. Acceptance or refusal decisions.
FDA's CBP role: FDA cannot physically stop a shipment — only CBP can do that. FDA instructs CBP to hold or refuse. FDA field investigators conduct physical examinations of held shipments at CBP-controlled ports.
FDA's Import Operations is organized by district — there are 13 ORA districts, each responsible for ports in their region.
FDA's CBP role: FDA cannot physically stop a shipment — only CBP can do that. FDA instructs CBP to hold or refuse. FDA field investigators conduct physical examinations of held shipments at CBP-controlled ports.
FDA's Import Operations is organized by district — there are 13 ORA districts, each responsible for ports in their region.
// The Key Operational Principle
FDA Decides. CBP Enforces. The Importer Bears the Cost.
When FDA determines a shipment is inadmissible, it is CBP that physically prevents entry. But the financial consequences — storage costs, re-export shipping, destruction costs, product loss — fall entirely on the importer of record. An importer of record who imports non-compliant product is legally and financially responsible for the consequences, regardless of whether the manufacturer caused the problem. This is why U.S. importers actively screen their foreign suppliers for compliance — and why well-prepared foreign manufacturers are far more attractive trading partners.
The Complete Import Flow — From Ship to Shelf
PRE
Pre-Shipment — Before the Product Leaves the Factory
All compliance work that should be done before the product ships. Facility registration confirmed current (FEI valid). Label review completed and approved. For food: Prior Notice filed and confirmation number obtained. For drugs: establishment registration current, annual fee paid. For devices: device listing current, UDI submitted to GUDID. Import broker engaged and given all compliance documentation. Shipper confirms all details match what will appear in the CBP entry.
💡 Every import problem that can be fixed before shipment is vastly cheaper to fix at this stage than after a container has arrived at a U.S. port.
1
Arrival and CBP Entry Filing
When the vessel, aircraft, or truck arrives at the U.S. port of entry, the importer of record (or their licensed customs broker) files an import entry through ACE. The entry includes: Harmonized Tariff Schedule (HTS) code, value, country of origin, manufacturer, shipper, consignee, and for FDA-regulated products, the FDA product code and the facility's FEI number.
For food products: the Prior Notice confirmation number must be included in the entry or the shipment cannot clear. CBP transmits the entry data electronically to FDA's screening systems within minutes of filing.
For food products: the Prior Notice confirmation number must be included in the entry or the shipment cannot clear. CBP transmits the entry data electronically to FDA's screening systems within minutes of filing.
2
FDA PREDICT Screening
FDA's PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) system analyzes each entry using a risk-based algorithm. PREDICT scores every shipment on dozens of risk factors and determines whether to: automatically release the shipment, flag it for document review, or flag it for physical examination. The vast majority of compliant shipments from registered, compliant facilities with clean histories pass through PREDICT without examination.
📊 FDA examines approximately 1–2% of all food entries. However, shipments from facilities with compliance history problems, on import alerts, or from high-risk country-product combinations are examined at much higher rates.
3A
Outcome A: Automatic Release
PREDICT scores the shipment as low risk. FDA issues an electronic release message to CBP. CBP releases the shipment for entry. The importer pays duties and the product enters U.S. commerce. No FDA action taken. This is the outcome for the majority of shipments from compliant, registered facilities with clean import histories.
3B
Outcome B: Held for Examination
PREDICT flags the shipment for examination. CBP holds the merchandise at the port or a bonded warehouse. FDA issues a Notice of Action to the importer of record. FDA field staff will conduct one or more of:
Document review: Review of labeling, certificates, test results, facility registration documents — without physically accessing the product
Physical examination: FDA investigators open the shipment, examine the product and labeling for admissibility violations
Sample collection: Samples collected for laboratory testing (pesticide residues, drug residues, microbial contamination, ingredient verification, undeclared substances)
Document review: Review of labeling, certificates, test results, facility registration documents — without physically accessing the product
Physical examination: FDA investigators open the shipment, examine the product and labeling for admissibility violations
Sample collection: Samples collected for laboratory testing (pesticide residues, drug residues, microbial contamination, ingredient verification, undeclared substances)
⏱️ Storage costs accumulate from Day 1 at the importer's expense. If the examination takes 2–3 weeks, storage costs on a full container can reach $3,000–$8,000 before any compliance decision is made.
4A
Examination Result: Released
FDA examination finds no admissibility violation. Release message issued. Shipment enters commerce. Importer pays the storage costs that accrued during examination — even though the product was ultimately compliant. This is another cost of non-preventive compliance — even clean shipments held for examination cost money.
4B
Examination Result: Notice of Detention and Hearing
FDA determines the shipment appears to be in violation. FDA issues a Notice of Detention and Hearing to the importer of record. The notice specifies: the article detained, the grounds for detention (the specific FDA regulation(s) violated), and the date by which the importer must respond. The importer has a right to present testimony within the time specified — typically 10 working days. During this hearing period, the shipment remains detained at the port or bonded warehouse at the importer's expense.
⚖️ The hearing is an opportunity — not a formality. A well-prepared response to a detention notice, with supporting documentation, can result in release even after initial detention. Engage a regulatory consultant or attorney immediately upon receiving a Notice of Detention.
5A
Hearing Response: Release After Reconsideration
The importer submits documentation, test results, or other evidence demonstrating the article is admissible. FDA reviews and agrees — issues release. This outcome is possible for: labeling violations (relabeling may be permitted), documentation issues (missing certificates provided), or cases where FDA's initial determination was based on incomplete information.
5B
Reconditioning — Bringing the Article into Compliance
For some violations — particularly labeling violations — FDA may permit the importer to recondition the article to bring it into compliance before release. Reconditioning involves correcting the specific violation under FDA supervision. Common reconditioning: relabeling (correcting labeling violations under FDA supervision at a bonded warehouse), removal of non-compliant components, or correction of net quantity declarations. The importer must submit a reconditioning plan for FDA approval, perform the work, and have FDA re-examine the article before release.
💼 Reconditioning is expensive and logistically complex but is often preferable to refusal. Costs include: storage fees, labor for reconditioning work, FDA re-examination fee, and delay in product availability. Reconditioning is typically not permitted for adulterated products (contamination, prohibited ingredients) — only for misbranding violations.
5C
Notice of Refusal — The Final Outcome
FDA determines the article is inadmissible and issues a Notice of Refusal of Admission. The importer has 90 days from the date of refusal to either: (1) re-export the article under CBP supervision, or (2) destroy the article under CBP supervision. If neither is done within 90 days, CBP may destroy the article at the importer's expense with no further notice. There is no appeal of a Notice of Refusal that suspends the 90-day clock — the importer must act regardless of whether they intend to challenge the refusal.
💸 A fully refused container of, say, $150,000 of food products: product value lost + $8,000–15,000 in storage costs + $15,000–25,000 for re-export shipping back to origin = $170,000–$190,000 total financial impact. This is why pre-shipment compliance is not optional.
PREDICT — How FDA's Risk Scoring Works
PREDICT is FDA's predictive risk-based targeting system — it analyzes import entries before physical examination to identify the shipments most likely to have compliance violations. Understanding what factors drive higher PREDICT scores helps you advise clients on how to reduce their examination rate over time.
High-Risk Factors — Triggers Examination
• Facility on an active import alert
• Facility with recent FDA Warning Letter
• Previous refusal history for this facility or importer
• Product-country combination with known compliance problems (e.g., aquaculture from certain countries)
• Product type with elevated contamination risk (e.g., leafy greens for E. coli, spices for Salmonella)
• First-time importer or first-time facility entry into U.S. market
• Facility with recent FDA Warning Letter
• Previous refusal history for this facility or importer
• Product-country combination with known compliance problems (e.g., aquaculture from certain countries)
• Product type with elevated contamination risk (e.g., leafy greens for E. coli, spices for Salmonella)
• First-time importer or first-time facility entry into U.S. market
Medium-Risk Factors — May Trigger Review
• Facility not recently inspected by FDA
• No FSVP documentation from U.S. importer
• Facility registered but not covered under a third-party audit program
• Product with recent public health concerns (e.g., Cronobacter in infant formula, PFAS in packaging)
• Country with known regulatory gaps for the specific product category
• No FSVP documentation from U.S. importer
• Facility registered but not covered under a third-party audit program
• Product with recent public health concerns (e.g., Cronobacter in infant formula, PFAS in packaging)
• Country with known regulatory gaps for the specific product category
Low-Risk Factors — Supports Release
• Clean import history — multiple successful entries with no violations
• Facility recently inspected and found compliant by FDA
• Facility certified under an FDA-recognized third-party certification program
• U.S. importer has current FSVP documentation
• Product from a country with an FDA-recognized food safety system
• Voluntary qualified importer program (VQIP) enrollment
• Facility recently inspected and found compliant by FDA
• Facility certified under an FDA-recognized third-party certification program
• U.S. importer has current FSVP documentation
• Product from a country with an FDA-recognized food safety system
• Voluntary qualified importer program (VQIP) enrollment
The Voluntary Qualified Importer Program (VQIP)
VQIP is FDA's voluntary program allowing U.S. food importers to pay an annual fee (~$16,000) for expedited review and release of food shipments. VQIP-enrolled importers must: use only FDA-recognized third-party accredited auditors for all their foreign suppliers, maintain continuous compliance, and meet all FSVP requirements. In exchange, their shipments receive a lower PREDICT risk score and faster automated release. For high-volume food importers, the VQIP fee is often justified by reduced examination costs and faster customs clearance.
Import Alerts — The Most Serious Import Status
An import alert (IA) is a formal FDA notice to CBP field staff instructing them to detain shipments from a specific firm, product, or country-product combination without physical examination — called "DWPE" (Detention Without Physical Examination). Import alerts represent FDA's highest-level enforcement mechanism for repeated or serious import violations.
IA 66-40
Drugs — Non-Current GMP
The most significant pharmaceutical import alert. Covers drug manufacturers (primarily foreign generic manufacturers) whose facilities do not comply with cGMP. All drugs from listed facilities are detained without examination. Adding a facility to IA 66-40 effectively blocks all drug imports from that facility until the GMP issues are resolved and FDA removes the listing. Many Indian and Chinese pharmaceutical facilities have been on IA 66-40 at various points.
IA 66-41
Drugs — Misbranding (OTC)
Covers OTC drug products found to be misbranded — typically products marketed with unapproved claims, missing required label elements, or products marketed as OTC drugs that don't conform to any approved monograph. Commonly triggered by supplement products marketed as OTC drugs without NDA compliance.
IA 99-32
Foods — Filth, Decomposition, and Other Physical Contamination
Covers food products found to be adulterated with filth, insect fragments, rodent contamination, or decomposition. Once a facility is listed, all subsequent shipments are detained. DWPE can be lifted only when the facility demonstrates it has corrected the conditions leading to the listing.
IA 16-129
Aquaculture — Unapproved Drug Residues
Covers aquaculture products (shrimp, catfish, basa/pangasius, dace, eel) from specific countries and/or facilities where unapproved drug residues have been repeatedly detected. Among the most actively enforced import alerts — new facilities are regularly added as FDA testing reveals chloramphenicol, nitrofurans, malachite green, or fluoroquinolone residues.
IA 45-02
Cosmetics — Microbial Contamination or Prohibited Ingredients
Covers cosmetic products found to be adulterated — typically through microbial contamination, prohibited ingredients (mercury in skin-lightening products is a common trigger), or products marketed with drug claims. Mercury import alert for cosmetics is among the most actively enforced.
IA 54-15
Devices — Non-Registered Facilities / No 510(k)
Covers medical devices from unregistered facilities or devices marketed without a required 510(k) clearance or PMA approval. DWPE applied to all devices from listed facilities. Registration alone is not sufficient to avoid this alert — the device must also have the required marketing authorization.
How to Get Off an Import Alert
Removal from an import alert is a deliberate, documented process — it does not happen automatically when violations are corrected. The process varies by alert type but generally requires:
1
Identify the Basis for the Alert
Review the import alert at accessdata.fda.gov/cms_ia/. Identify the specific charges under which the facility or product is listed. Each alert has a "reason for alert" that tells you exactly what FDA found and what must be corrected. This becomes the roadmap for the remediation plan.
2
Develop and Implement a CAPA Plan
Prepare a comprehensive Corrective and Preventive Action (CAPA) plan addressing every charge cited in the import alert. The plan must: identify root causes, describe corrective actions taken, establish preventive measures to ensure recurrence doesn't happen, and include a timeline with documented completion dates. For drug GMP alerts, this means conducting a full GMP gap assessment and implementing all corrections with documented evidence.
3
Produce Evidence of Correction
Compile comprehensive documentation of all corrective actions: updated SOPs, training records, equipment qualification records, testing data, audit results, and photographs where appropriate. For drug GMP issues: updated batch records, data integrity remediation evidence, and if possible, a third-party GMP audit report confirming the corrections have been implemented.
4
Option A: Satisfy the Alert Through Testing (Food/Cosmetic)
For some import alerts, DWPE can be lifted for a specific shipment if the importer provides private laboratory test results showing the specific article does not contain the violative substance. The test must be conducted by an FDA-recognized laboratory, must cover all cited violative substances, and must use FDA-approved methods. This allows individual shipments to clear even while the facility remains on the alert — providing a short-term path to continued trade while the facility-level corrections are being made.
5
Option B: Request Removal from Alert (Drug GMP / Devices)
For drug GMP import alerts and device-related alerts, private laboratory testing is not sufficient — the facility itself must be re-inspected by FDA and found to be in compliance before removal. This means: (1) requesting an FDA inspection through formal channels, (2) having the inspection completed with no Significant Objectionable Conditions (SOCs), and (3) receiving FDA's written confirmation of removal from the alert. Timeline for this process: typically 12–36 months depending on FDA inspection scheduling and the extent of corrections required.
Grounds for Refusal — Know What Gets Products Refused
| Refusal Ground | Legal Basis | Most Common Products | Preventable By |
|---|---|---|---|
| Adulteration — Unsafe | 21 U.S.C. § 342(a) / § 351(a) | Food with pathogens; drugs with contamination; cosmetics with prohibited ingredients | Proper GMP, microbiological testing before export, ingredient verification |
| Adulteration — Insanitary Conditions | 21 U.S.C. § 342(a)(4) | Food; dietary supplements; drugs | FDA or equivalent GMP compliance; clean facility inspection results |
| Adulteration — Unregistered Facility | 21 U.S.C. § 342(j) | All food products; dietary supplements | Complete facility registration before first shipment; maintain current registration |
| Misbranding — False/Misleading | 21 U.S.C. § 343(a) / § 352(a) | All categories; especially supplements and cosmetics with drug claims | Comprehensive label review; digital content audit |
| Misbranding — Missing Required Information | 21 U.S.C. § 343(e) / § 352(b) | All categories; especially imported products with foreign-language labels | Label review checklist; English translation requirement compliance |
| Unapproved New Drug | 21 U.S.C. § 355(a) | Supplements with disease claims; cosmetics with drug claims; foreign drugs without NDA | Claims review; classification analysis before export |
| Drug from Unregistered Facility | 21 U.S.C. § 331(p) | Pharmaceuticals; OTC drugs | Annual drug establishment registration; fee payment |
| No Prior Notice (Food) | 21 U.S.C. § 381(m) | All food products | Filing Prior Notice before every shipment; providing confirmation number to customs broker |
| Device from Unregistered Facility / No 510(k) | 21 U.S.C. § 351(h) / § 360(k) | Medical devices | Annual device establishment registration; 510(k) or PMA before marketing |
Prior Notice — The Food Import Pre-Entry Requirement
Prior Notice is covered in Module 05 but deserves a deeper operational treatment here because getting it wrong is expensive and there are no second chances once a shipment is en route. Here is the operational detail every consultant needs.
Prior Notice Filing — Operational Checklist
System: FDA's Prior Notice System Interface (PNSI) at access.fda.gov
OR via CBP's Automated Broker Interface (ABI) — used by licensed customs brokers
What triggers a NEW Prior Notice (vs. amendment):
→ Each separate shipment arriving at a separate time requires its own Prior Notice
→ The same shipment changing ports of entry requires an amendment BEFORE arrival
→ The same product on multiple trucks/containers requires separate PNs unless filed as one lot
Timing deadlines (hard cutoffs — no extensions):
Air: 4 hours before arrival at first U.S. port
Ocean/Water: 8 hours before arrival
Rail: 4 hours before arrival
Road/Truck: 2 hours before arrival at border crossing
The PN Confirmation Number:
→ Generated automatically when PN is submitted
→ Must be given to the customs broker before arrival
→ CBP requires PN confirmation number before processing food entry
→ A shipment arriving at a port with no PN confirmation = automatic refusal
→ There is NO ability to retroactively file after the shipment has arrived
PN Validity Window:
→ Prior Notice is valid for 5 days before the anticipated arrival date
→ If the shipment is delayed more than 5 days: cancel and refile
→ If the shipment arrives early: the PN is still valid if timing requirements met
What happens if FDA has questions after PN submission:
→ FDA may contact the submitter within the notice period
→ Respond promptly — FDA can hold the shipment if PN is incomplete or unclear
→ Do not attempt to withdraw and refile to avoid a question — FDA will notice
Reconditioning — Rescuing a Detained Shipment
Reconditioning is the process of bringing a detained, misbranded shipment into compliance under FDA supervision. It is available for labeling violations (misbranding) but generally not for adulteration. Understanding what can and cannot be reconditioned shapes how you advise clients on detention response strategy.
✅ Generally Eligible for Reconditioning
• Missing required label elements (net quantity, manufacturer address, allergen declaration)
• Wrong label format (old Nutrition Facts format, wrong net quantity presentation)
• Foreign language only — adding English stickers over label
• Missing required warnings or disclaimers
• Products without English instructions (devices, cosmetics)
• Missing NDC number or NADA statement (relabeling)
Process: Importer submits reconditioning proposal → FDA approves → work done under bond at bonded warehouse → FDA re-examines → release if compliant
• Wrong label format (old Nutrition Facts format, wrong net quantity presentation)
• Foreign language only — adding English stickers over label
• Missing required warnings or disclaimers
• Products without English instructions (devices, cosmetics)
• Missing NDC number or NADA statement (relabeling)
Process: Importer submits reconditioning proposal → FDA approves → work done under bond at bonded warehouse → FDA re-examines → release if compliant
🚫 NOT Eligible for Reconditioning
• Microbial contamination (Salmonella, Listeria, E. coli) — product must be destroyed
• Unapproved drug ingredients, prohibited color additives — adulteration cannot be relabeled away
• Products with drug claims on the label — the claim, not just the label, makes it a drug
• Products from unregistered facilities — the entire shipment is inadmissible regardless of label
• Devices without required 510(k) clearance — a relabeling cannot create marketing authorization
Outcome for these: Re-export (importer's cost) or destruction (importer's cost) within 90 days of refusal.
• Unapproved drug ingredients, prohibited color additives — adulteration cannot be relabeled away
• Products with drug claims on the label — the claim, not just the label, makes it a drug
• Products from unregistered facilities — the entire shipment is inadmissible regardless of label
• Devices without required 510(k) clearance — a relabeling cannot create marketing authorization
Outcome for these: Re-export (importer's cost) or destruction (importer's cost) within 90 days of refusal.
The Pre-Shipment Compliance Checklist
The cheapest way to handle import detention is to prevent it entirely. Use this checklist with every client before their first shipment — and verify the ongoing items for repeat shippers.
PRE-SHIPMENT COMPLIANCE CHECKLIST
// Verify before every shipment. Document each check.
Facility Registration (all categories)
□ Facility is registered with FDA (food/drug/device/cosmetic — applicable system)
□ Registration is current — not expired or cancelled
□ FEI or EI number confirmed and noted for customs broker
□ US Agent information current and US Agent is reachable
□ Annual fee paid (drugs, devices) or biennial renewal confirmed (food, cosmetics)
Product Compliance
□ Label review completed — all required elements present, in English, correct format
□ No drug/disease claims on label, website, Amazon, or social media
□ All ingredients have U.S. approval (GRAS, approved food additive, INCI for cosmetics)
□ Color additives U.S.-approved for specific application and use level
□ For supplements: no NDI issues; structure/function disclaimer present
□ For drugs: NDC number on label; annual fee paid; registration current
□ For devices: device listed in FURLS; UDI on label and submitted to GUDID
Import-Specific Requirements (Food)
□ Prior Notice filed and confirmation number obtained BEFORE shipment departs
□ PN confirmation number provided to customs broker
□ FDA product codes in Prior Notice match facility registration product categories
□ For FSMA-covered facilities: FSVP documentation available for U.S. importer
Import Alert Check
□ Confirmed facility is NOT on any active import alert
□ Check: accessdata.fda.gov/cms_ia/ — search by firm name and FEI number
□ If on import alert: private lab testing completed before shipment (if applicable)
Logistics and Documentation
□ Customs broker confirmed and briefed on FDA compliance requirements
□ Commercial invoice contains accurate product description and FDA product code
□ Country of origin documentation available
□ Certificates of analysis or compliance available if FDA requests them at port
// Real-World Scenario — The Three-Container Detention
When One Missing Detail Becomes a $180,000 Problem
A Bangladeshi garment manufacturer decides to expand into exporting processed foods — specifically, dried fruit and nut products — to a U.S. distributor. They have been producing food for their domestic market for years and assume their quality is sufficient. Three containers of product arrive at the Port of Baltimore. PREDICT flags all three for examination. Here is what FDA finds:
- Problem 1: No FDA facility registration. The Bangladeshi facility has never registered with FDA — no FEI number exists. All three containers are immediately inadmissible as adulterated under 21 U.S.C. § 342(j) (adulteration by virtue of being from an unregistered facility).
- Problem 2: No Prior Notice was filed for any of the three shipments. Even if the facility were registered, the shipments would be refused for this reason alone.
- Problem 3: One product contains a tree nut blend with no English allergen declaration. The label is entirely in Bengali. Automatic misbranding, undeclared allergens = Class I recall risk.
- Problem 4: Laboratory testing of samples from container #2 detects aflatoxin contamination at levels exceeding FDA's action level of 20 ppb. That container's product is adulterated and must be destroyed. Reconditioning not available.
Three containers refused. Storage accrued: $22,000 over 5 weeks. Re-export for containers #1 and #3: $31,000. Destruction of container #2: $8,500. Product value lost: $140,000. Total financial impact: approximately $200,000+.
The U.S. distributor terminates the supplier relationship. The Bangladeshi manufacturer is now on FDA's radar as a repeat non-complier, increasing PREDICT risk scores for any future attempts to enter the U.S. market.
🚫 Every single issue in this scenario would have been identified and resolved by a pre-shipment regulatory consultation. The total cost of a full compliance engagement — registration, label review, Prior Notice setup, FSMA assessment — would have been under $5,000. The total loss: $200,000+.
✦ Module 13 — Key Takeaways
- Two agencies share import authority: CBP controls physical entry and processes import entries through ACE; FDA evaluates FDA-regulated products for compliance and instructs CBP to hold or refuse inadmissible shipments. The importer of record bears all financial consequences regardless of which party caused the violation.
- PREDICT is FDA's risk-based screening system. It scores every import entry using dozens of factors including facility compliance history, prior refusals, product-country risk profiles, and import alert status. Clean compliance history significantly reduces examination rates — every compliant shipment builds toward lower future risk scores.
- The import detention process has specific time windows: Notice of Detention gives the importer typically 10 working days to respond. Reconditioning must be proposed and approved before FDA issues a Notice of Refusal. After a Notice of Refusal, the importer has 90 days to re-export or destroy — this clock cannot be suspended by administrative challenge.
- Import alerts (DWPE — Detention Without Physical Examination) are FDA's most severe import enforcement tool. Getting added to an import alert effectively blocks all exports to the U.S. from the affected facility. Getting off an import alert requires either private laboratory testing (for some food/cosmetic alerts) or an FDA re-inspection with clean results (for drug GMP and device alerts).
- Prior Notice for food imports has hard timing deadlines: 2 hours (truck), 4 hours (air/rail), 8 hours (ocean). There is no after-the-fact filing option. A shipment arriving at port without a PN confirmation number is automatically refused. The confirmation number must be in the customs broker's hands before the shipment arrives.
- Reconditioning is available for misbranding violations (labeling errors) but not for adulteration (contamination, prohibited ingredients, unapproved drugs). The distinction between misbranding (fixable with relabeling) and adulteration (product must be re-exported or destroyed) shapes detention response strategy.
- The pre-shipment compliance checklist — covering registration, labeling, ingredient safety, import alert status, Prior Notice, and documentation — is the operational foundation of every Regovant client engagement. One missed item can cost more than the entire compliance engagement. Prevention costs pennies on the dollar compared to detention.
Detained at the border? Or preparing for your first U.S. shipment?
Regovant advises on detention responses, reconditioning plans, import alert removal strategies, and pre-shipment compliance for exporters in 60+ countries.