FDA Detained Your Shipment? Here's What to Do in the First 48 Hours

Why FDA Detains Shipments

FDA may detain (formally called "Detention Without Physical Examination" or DWPE) an imported article of food, drug, device, or cosmetic if it appears to violate the FD&C Act. Common reasons include:

• No valid facility registration: The foreign facility's FDA registration is expired, missing, or has no active U.S. Agent
• Prior Notice issues: The Prior Notice was not filed, was filed late, or contained incorrect information
• Import Alert: The product or manufacturer is listed on an active FDA Import Alert, allowing detention without physical examination
• Labeling violations: Product labels do not meet FDA requirements (missing ingredient lists, unapproved claims, etc.)
• Adulteration: FDA suspects the product is adulterated — contaminated, manufactured under insanitary conditions, or containing unapproved additives
• Missing FSVP documentation: The U.S. importer cannot demonstrate FSVP compliance

The First 48 Hours: Critical Steps

Time is critical when a shipment is detained. Storage fees accumulate daily (often $100–$500+/day depending on the port and product type), and perishable goods may deteriorate. Here is what to do immediately:

Step 1: Get the Detention Notice

Contact your customs broker immediately and request a copy of the FDA detention notice. This document will specify the reason for detention, the specific FD&C Act section allegedly violated, and the product involved. Without this notice, you cannot formulate an effective response.

Step 2: Identify the Violation

Read the detention notice carefully. Is the issue a registration problem, a labeling violation, an Import Alert, or a suspected adulteration? The resolution strategy depends entirely on the type of violation.

Step 3: Gather Evidence

Collect documentation that addresses the specific violation:

• For registration issues: Obtain proof of active FDA registration and U.S. Agent confirmation
• For labeling: Provide corrected labels or evidence that existing labels comply
• For adulteration: Provide certificates of analysis (COAs), third-party lab test results, or manufacturing records
• For Import Alerts: Begin the petition process (see our Import Alert removal guide)

Step 4: Contact FDA's Division of Import Operations

You have the right to provide testimony and introduce evidence to overcome the appearance of a violation, per Section 801(a) of the FD&C Act. Your customs broker or regulatory consultant can help you submit an informal hearing request or present evidence directly to the FDA district office handling the detention.

Common Outcomes After Detention

• Release: If you successfully overcome the appearance of violation, FDA will release the shipment for entry into U.S. commerce
• Conditional release: FDA may release the shipment on the condition that you bring the product into compliance (e.g., relabeling)
• Refusal of admission: If you cannot overcome the violation, FDA will formally refuse the shipment. You then have the option to re-export or destroy the goods
• Seizure: In severe cases (public health risk), FDA may seize the goods through a court order

Preventing Future Detentions

The best strategy is prevention. Here are key steps to avoid detentions:

1. Maintain active FDA registration: Ensure your foreign facility's registration is current and has an active U.S. Agent. Use Assurentry to manage your registration.
2. File accurate Prior Notices: Double-check product codes, arrival times, and facility registration numbers before filing.
3. Monitor Import Alerts: Check FDA's Import Alert database regularly to see if your products or country of origin are flagged.
4. Verify labeling compliance: Review all product labels against current FDA requirements before shipping.
5. Maintain FSVP documentation: Keep your Foreign Supplier Verification Program records organized and accessible.