How to Respond to an FDA Import Detention in 72 Hours [2025 Guide]

When FDA holds a shipment, speed comes from clarity. Identify the hold type, use ITACS to see real-time status, and respond to the Notice of FDA Action by the stated date with evidence that addresses the charge. This playbook gives you the steps and the proof points you can cite.

TLDR

Confirm the hold type and the specific charge listed on the Notice of FDA Action. Your response must match that charge.
FDA’s Regulatory Procedures Manual allows 10 business days to respond to a detention. Notices often show 20 calendar days to allow for weekends and mailing time.
Use ITACS to check status, upload documents, and see estimated lab completion dates. CBP will not release the entry until all FDA holds are cleared.

Step 1. Identify the hold and gather the right evidence

Ask your broker and the FDA compliance officer for the exact charge and what will overcome the appearance of a violation. Then assemble a response packet that maps evidence to each charge.

Check status in ITACS with the CBP entry number. Upload documents through ITACS and retrieve Notices of FDA Action there.
Map evidence to charge. Examples: labeling fixes for misbranding, validated CoAs and method data for adulteration claims, registration or listing proof for devices, prior notice corrections for food.
For DWPE under an Import Alert, plan for stronger evidence. You may need private lab testing and, for removal from DWPE, a series of compliant shipments.
If reconditioning is needed, request permission using Form FDA 766 and describe the exact action to bring the product into compliance.

Proof note you can cite in emails

“FDA’s Regulatory Procedures Manual allows 10 business days for testimony following detention. Notices often specify 20 calendar days. Use ITACS to submit documents and monitor status. DWPE requires evidence that resolves the violation cited in the import alert.”

Step 2. The first 72 hours

Hour 0 to 24

Pull the entry packet. Include invoice, packing list, HS codes, country of origin, process controls or HACCP where relevant, and any Affirmation of Compliance data.
Log into ITACS. Confirm current status, any document requests, and lab sampling state.
Email the FDA compliance officer listed on the Notice to confirm the charge, the respond by date, and whether private lab evidence is appropriate.

Hour 24 to 48

If the charge is fixable by relabeling or reconditioning, submit Form FDA 766 for authorization and prepare the action plan.
If private lab testing is appropriate, commission a lab that can deliver a compliant Private Laboratory Analytical Package (PLAP) that meets FDA guidance.
For prior notice or data errors, correct the submission and document the correction path.

Hour 48 to 72

Upload evidence through ITACS. Reference the specific charge in your cover letter and list attachments.
Keep a contemporaneous log of status checks, sampling dates, and any unavailability. CBP release will wait until FDA clears the hold.
If you need more time for lab work, request an extension from the compliance officer before the respond by date.

Common FDA scenarios and what clears them

Scenario	What it means	What often clears it
Detention for misbranding	Labeling errors or missing required info	Corrected label proofs and a reconditioning plan via FDA 766
Detention for adulteration	Product appears unsafe or contaminated	Validated lab results in a compliant PLAP package and process controls
Detention Without Physical Examination (DWPE)	Import Alert based on past violations	Evidence that resolves the violation and, for removal from DWPE, a pattern of compliant shipments
Hold for examination or sampling	FDA will examine or sample product	Provide product location through ITACS and wait for lab completion date
Prior Notice issues	Food PN missing or incorrect	Submit or correct PN and confirm in ITACS

Timing depends on product type, lab queues, and the complexity of the charge. Treat durations as planning ranges, not promises.

The timers that matter

Respond by date. FDA policy allows 10 business days to respond to a detention. Notices often specify 20 calendar days. Request an extension in advance if needed.
Refusal and export. If you cannot overcome the violation, the product will be refused. You must destroy or export within 90 days of refusal.
Release dependency. CBP will not set entry to Released until FDA holds are cleared and any Prior Notice issues are satisfied.

Cut cost and delay while you wait

Use ITACS to submit documents, confirm sampling dates, and monitor estimated lab completion. Keep screenshots with timestamps.
If the shipment sits at a terminal, maintain a record of appointment attempts and any return restrictions. This supports later D and D disputes under FMC rules.
If reconditioning is approved, schedule labor and materials in advance so you can execute immediately after authorization.

Two copy-ready emails

Subject: FDA detention for [Entry number]. Clarify charge and evidence required

We received a Notice of FDA Action showing detention for [product]. Please confirm the specific charge and whether private lab evidence is appropriate. The respond by date on the Notice is [date]. We will submit through ITACS and reference the charge in our cover letter. If reconditioning is possible, we will file FDA 766 for authorization.

Subject: Immediate documents needed for FDA response [PO / SKU]

FDA detained the shipment for [charge]. Please send within 24 hours: updated labels, process controls or HACCP summary, CoAs with method and LOQ, supplier registrations or listings, and any corrective action records. We will compile a PLAP-compliant package if lab evidence is required.

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References

FDA: Detention and Hearing (10 business day testimony window. Notices often show 20 calendar days. Options and extensions).
FDA ITACS portal and ITACS overview (status, document upload, lab completion estimates).
Entry Screening Systems and Tools and PREDICT overview (risk-based screening).
Import Alerts and DWPE and Removal from DWPE (evidence expectations and removal path).
CPG Sec. 150.200: Private Laboratory Analytical Packages and Private Laboratory Testing (PLAP standards).
CBP ACE Cargo Release FAQ (release waits for holds to clear and Prior Notice to be satisfied).
21 U.S.C. § 381 (imports authority. Prior Notice for food).

This guide is general information for containerized ocean freight operations. It is not legal or compliance advice. Rules and clocks are jurisdiction specific and can change. Verify with your licensed customs broker, customs attorney, and the relevant agency before acting. Last reviewed: August 12, 2025.

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