Detention without physical examination, and how to answer it.

What DWPE means for an entry

When a product is subject to DWPE, FDA does not need to examine the shipment in order to detain it. The entry is flagged in the agency's screening system and you receive a Notice of FDA Action stating the charge and the deadline to respond — generally ten working days to submit testimony.

Testimony here means documentary and analytical evidence that this specific shipment is not violative. Commercial arguments, letters of good standing and a clean history are not testimony.

The three ways an entry ends

• Release. You present laboratory results and supporting documentation that overcome the appearance of a violation, and FDA releases the entry.
• Reconditioning. Where the defect can be corrected — relabeling, sorting, reprocessing — you apply to recondition, carry out the work under supervision, and present the result for FDA's approval.
• Refusal. If nothing is presented, or the evidence does not hold, the entry is refused and must be exported or destroyed under CBP supervision, at your cost.

A refusal is not only the loss of one container. It becomes part of the record that keeps the firm on the alert.

What makes testimony hold

• A laboratory FDA will accept, using the method FDA uses for that analyte, with detection limits at or below the action level.
• A sampling plan that represents the lot, not a single convenience sample.
• Complete chain of custody from the container to the bench.
• Documentation that connects the sample to the entry line, the invoice and the lot codes without gaps.

What we do

We review the Notice of FDA Action and the charge, select and coordinate the laboratory, build the testimony package, and prepare reconditioning applications where that is the better route. In parallel we start the corrective work a removal petition will later need.

Answering the entry and getting off the alert are two different projects. The first buys you the shipment; only the second stops the next one being detained.

Common questions

What is the difference between an import alert and DWPE?

The import alert is the instruction; DWPE is its effect. The alert tells FDA staff that products meeting a description may be detained without examination, and DWPE is the detention that follows at the port.

How long do we have to respond to a detention?

The Notice of FDA Action states the deadline, generally ten working days from the notice. Extensions are possible but must be requested. Letting the deadline pass without a response leads to refusal.

Can a private laboratory result be enough?

Yes — private laboratory analysis is the normal route. What matters is that the laboratory, the method and the documentation meet FDA's expectations. A result from a laboratory that cannot show its method and credentials is rarely persuasive.

Does one released entry get us off the list?

No. Release resolves that shipment. Removal from the alert requires a separate petition supported by corrective action and a record of sustained compliance.