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U.S. Food and Drug Administration (FDA) Regulations
•
A series of non-violative
shipments
to verify the
corrective or preventive actions are sufficient. There
is a minimum of 5-12 routine commercial shipments
spaced over a reasonable period of time. Submission
of shipping documents such as US Customs form 3461
or 7501, commercial invoice, packing list and bill of
lading, are required.
b. FDA Review of Petitions
DIO reviews the petitions in the order received. Review
period can take several months. FDA may request
additional documentation or shipments during the course
of the review.
If the petition is approved, FDA will issue an approval
letter to the submitter and notify all FDA district offices of
the change in status. Entries will no longer be subject to
DWPE, but will remain subject to routine inspections.
However, if petition is denied, FDA will issue a denial letter
to the submitter including an explanation of the reason for
denial. Once any deficiencies have been corrected, a new
petition may be submitted to FDA for further review. No
penalty for a denied petition.
c. DWPE Petition Assistance
U.S. Agent can assist the company to identify the cause of
placement on import alert. They assist in the determination
and implementation of certain types of corrective actions
such as label reviews, HACCP reviews, FCE/SID filing,
registration, colour batch certification, etc. Assistance
to communicate with FDA will also be provided for each
detained shipment after implementation of corrective
actions. It develop petition for removal from DWPE and
submit to FDA by providing an administrative review of
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