Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Steps to evaluate the progress of an FDA recall

Once a Food and Drug Administration recall is initiated, a company is responsible for evaluating the progress of the recall of the medical device, drug, biological product, or package, and providing routine updates to the FDA. The three parts of a recall evaluation include the following: 1. An effectiveness check is necessary to verify that the notification letter was received by the customer and that the recalled product has been handled appropriately. For more information, see methods for conducting recall effectiveness checks. 2. A recall status report is routinely provided to the local FDA district recall coordinator. One of the components of the status report is the determination of the root cause. In addition, the report includes the number of customers notified and the customer responses. 3. In order to terminate the recall, all product possible must be recovered. Once this occurs and the disposition of the recalled product has been completed, a final status report can be generated.

More detailed information on the regulations, guidance, effectiveness check letters, and enforcement reports is available on the FDA's recall Web page.

--By Linda McBride, Registered Pharmacist

Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report