Removal from the FDA’s Red List also known as Detention without Physical Examination (DWPE)
You may submit a petition to DIOP’s Operations and Policy Branch for removal from DWPE. In your petition, you should outline the corrective actions and steps taken by the firm to prevent the problem which led the firm to be placed on the import alert.
Individual Import Alerts may have specific information regarding removal from detention without physical examination. You should review the import alert specific to your request, and ensure you submit any and all documentation called for. You can access FDA’s Import Alerts here.
Additionally, you should supply information relating to a minimum of 5 entries which were shipped to the U.S., and subsequently analyzed or examined and found to no longer be in violation. Submit the following documents for each entry you supply in support of your petition:
US Customs Form 3461 or US Customs Form 7501
Bill of Lading
(please note you do not need to submit the actual private laboratory results)
For facilities that have been removed from the ‘Automatic Detention’ also known as ‘Detention without Physical Examination’ (DWPE) list, the confirmation of cancellation and new facility registration confirmation must be sent to the FDA with a copy of the following forms:
Business document from the firm indicating the correct address of the new facility location (as stated on the new registration), such as a letter to FDA on the firm’s letterhead, explaining the move, the effective date of the move and a statement the firms intends to continue using the same process as the old facility.
Government issued documentation such as a license/registration, tax identification form, etc which indicates the new facility address.
Please note the producer has the responsibility in providing any corrections such as changes of addresses to DIOP, and the importer will have to deal with the detentions if the change or update is not done before they continue with the importations. Updates like this one, if not officially reflected in the green list of the alert thru DIOP, will only cause the importer unnecessary and unavoidable delays.