CBP LA Details Procedures for CBP/FDA Refused Merchandise

December 26, 2012 by Tim Warren|Customs

CBP Los Angeles/Long Beach is updating its port procedures for the disposition of merchandise refused by the Food and Drug Administration (FDA), it said in a public bulletin dated Dec. 21. The bulletin also notified the public that the Federal Destruction and Redelivery Team (Team FDR) will process documentation on FDA refused merchandise, it said.

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The FDA and CBP created the Team FDR, which is comprised of personnel from both agencies, as part of enforcement of Section 801 of the Food, Drug and Cosmetic Act .

Updated Refused Merchandise Processing

All merchandise refused by the FDA must be exported or destroyed under CBP and FDA supervision within 90 days of the refusal date, the notice said.

Instead of a separate CBP Form 4647 and Notice of FDA Action (Refusal), the importer will receive a combined Refusal Redelivery Notice (RRN).
The RRN will indicate redelivery and a cover sheet with port specific instructions for exportation or destruction of FDA refused merchandise will be included.
If the refused product has been distributed, it's the importer's responsibility to recall and redeliver the products into CBP custody for exportation or destruction.
Such goods much be redelivered in a single location within the Port of LA/Long Beach FDA Sampling Area unless otherwise authorized by the FDA. The merchandise must be held intact until the FDA issues an official "May Proceed" or "Release" notice. The product must remain in their original shipping cartons until released by the FDA or authorized on an FDA reconditioning approval. If a shipment is destined outside the sampling area and must be moved immediately, it's recommended that the In-Transit Customs Bond procedures are used for filing the CBP and FDA entry package at the final destination.

Filing CBP Form 7512 for Merchandise for Exportation in ACE

To file CBP Form 7512 for Transportation Entry of Immediate Exportation in ACE, the broker/importer should provide the RRN, coversheet, other shipment documentation and a copy of the CBP Form 7512 to the Dock Exam Team, indicating plans to use ACE for submission. The FDA will next contact the broker to set up an appointment and the broker will then transmit CBP Form 7512 though ACE before the appointment.

Filing CBP Form 7512 for Merchandise for Exportation Outside of ACE

To file CBP Form 7512 outside of ACE, the importer/broker must file Form 7512 with the Dock Exam Team along with the RRN, coversheet and other shipment information. The package must be filed in the Dock Exam Team bin at 301 E. Ocean Blvd., Long Beach, CA 90802. Each original and copy of Form 7512 must say "For Export Only-No diversion permitted Merchandise Refund Admission by FDA."

Merchandise for Destruction

To destroy FDA refused merchandise, the importer/broker must file a CBP Form 3499 to the Dock Exam Team along with the RRN, coversheet and other shipment details.
The Dock Exam Team will then forward the form to the FDA, which will then schedule an appointment to witness the destruction of the refused merchandise.
After destruction the FDA Inspector that witnessed the destruction will return a signed CBP Form 3499 to the Dock Exam Team verifying the destruction and another copy will be sent to the broker/importer.

Contact: Harout Barsoumian (562) 366-5710.

Email ITTNews@warren-news.com for a copy of the public bulletin.

(LA13-011, dated 12/21/12)