How to Effectively Manage a Product Recall - Pharmaceutical Technology

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How to Effectively Manage a Product Recall
The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.


Pharmaceutical Technology
Volume 35, Issue 1

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,
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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