When FDA detains a shipment, the official response window is usually measured in business days, not minutes. But for food importers, the first hour still matters because that is when you decide who owns the response, whether the issue is evidence-based or relabel/reconditionable, and how fast you can get documents into FDA's hands. FDA's process starts with a Notice of Detention and Hearing. That notice tells you the apparent violation, the "respond by" date, and the compliance officer handling the case.
FDA says your basic options are to submit evidence, also called testimony, to overcome the appearance of a violation, or to request permission to relabel or recondition the product. If you do nothing, FDA can issue a refusal of admission. Once a shipment is refused, it must be destroyed or exported under FDA and CBP supervision within 90 days of the refusal notice.
Minute 0 to 15: Read the notice like a lawyer, not like a logistics coordinator
In the first 15 minutes, pull four facts out of the notice: the charge, the respond-by date, the FDA compliance officer, and who is legally positioned to respond. FDA says the owner or consignee may respond, and FDA also recognizes the importer of record as eligible to provide information about the shipment. A designated representative may respond too, but that authorization needs to be in writing.
Minute 15 to 30: Stop movement chaos
Your next move is operational control. Freeze ad hoc decision-making. Do not let multiple parties email FDA separately. Assign one lead. If the goods have been moved, confirm where they are. FDA says products are not required to be held in one specific place before admissibility is decided, but if the shipment has been moved outside the declared port area and FDA wants to examine or sample it, FDA may ask CBP to demand redelivery back to the port.
Minute 30 to 60: Choose the response path
By the end of the first hour, you want a provisional path, not a perfect answer. If the issue looks documentary or factual, start building testimony. If it looks fixable through labeling or other corrective action, prepare for a Form FDA 766 reconditioning request. If the product is under detention without physical examination and the issue is testable, private lab evidence may help, and FDA says you can request more time if lab work needs it. FDA's preferred submission channel for entry documents is ITACS.
What a good first-hour checklist looks like
- Pull and circulate the Notice of Detention and Hearing.
- Identify the exact charge and respond-by date.
- Confirm the authorized responder.
- Freeze unauthorized shipment movement and communications.
- Classify the issue: evidence, lab, or reconditioning.
- Start the ITACS submission file.
- Decide whether an extension is needed.
- Put supplier, QA, regulatory, and broker teams into one thread immediately.
That is the difference between a controlled response and a very expensive scramble.
Related reading: Perishable Shipments on FDA Hold · FDA Import Compliance · FDA Import Alerts Explained · Food & Beverage Imports