WASHINGTON, D.C. — The U.S. FDA and CBP have issued a revised compliance guide for the enforcement of the prior notice interim final rule (IFR).
The revised guide replaces the one issued in June. Under the revised CPG, FDA and CBP is now enforcing all provisions of the prior notice IFR excepting the following violations: – The registration number submitted for the manufacturing facility is wrong; – The registration number for the shipper is missing; – The Airway Bill number or Bill of Lading number missing or invalid; and – The name and address of the ultimate consignee is wrong because it contains the name and address of the express consignment operator or consolidator instead.
For the above violations, FDA and CBP will continue to exercise enforcement discretion until Nov. 1. That is, unless the violation reflects a history of repeated conduct of a similar nature by the same entity.
The revised guide also states enforcement discretion will be exercised for PNs that fail to include a required manufacturing facility registration number, but only if the food imported or offered for import is for quality assurance, research or analysis purposes (not for human or animal consumption and not for resale).
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