When is the product recall officially ended?
Recall communications have gone out, consignees have responded, product has been returned, status reports have been submitted,
effectiveness checks have been completed. One might think the recall is now over, however, that is not something a company
can decide. The official recall termination notice must come from FDA. A company can request that the recall be terminated
by submitting a recall summary report stating that all efforts have been exhausted for the product retrieval and justifying
that the recall strategy has been successfully and completely implemented. If FDA agrees, the recall termination letter will
be sent by FDA to the recalling company.
Product recalls are very time consuming, requiring cooperation, organization, and levelheadedness for a company to survive
relatively unscathed. Resources are often stretched to accommodate the increased requirements and the company usually becomes
under increased scrutiny by FDA from a compliance perspective.
No company wants to be involved in a product recall. However, if the situation is unavoidable, proper training, planning,
and execution of the recall can result in only minor operational and financial disruption.
Nancy Cafmeyer is a project manager, and Jonathan M. Lewis is a principal, both at Advanced Biomedical Consulting (ABC), St. Petersburg, FL, tel. 888.671.4292, fax 888.316.7537, info@advancedbiomedicalconsulting.com
http://www.abcforfda.com/.
References
1. Code of Federal Regulations, Title 21, Food and Drugs, Chapter 1 – Subchapter A – General (Government Printing Office, Washington, DC), Part 7
2. FDA, Guidance for Industry: Product Recalls, Including Removals and Corrections, (Rockville, MD, Nov. 3, 2003).
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