Notice of Detention and Hearing is issued by the FDA.
Your options include submitting:
■ evidence (testimony) to overcome the appearance of a violation.
■ a request to recondition the product to correct the violation.
If you are unable to overcome the appearance of a violation, your product will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days of the refusal.