We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies.
DEVICE | TEI Biosciences Inc.
TEI Biosciences Inc. (Plainsboro, NJ) received a warning letter on March 6, 2019 based on the outcome of an inspection ending November 2, 2018. The firm manufactures collagen-based medical devices used for wound care, soft tissue repair, and construction surgery.
Deficiencies include but are not limited to:
- Failure to validate the manufacture of the extracellular bovine matrix used in the medical devices. Also, the firm did not have data to demonstrate bacterial endotoxin testing has been validated appropriately.
- Data are not available to demonstrate adequate validation of the water system, and the firm does not routinely identify microbial isolated recovered from the water system.
- The firm failed to routinely incorporate a sporicidal agent into cleanroom cleaning since March 2017. The cleaning procedure does not describe the frequency or process of cleaning to prevent cross-contamination of areas. Personnel moved from areas of higher contamination to clean rooms.
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DEVICE | Sientra, Inc. and Mentor Worldwide LLC & Acclarent
Two manufacturers of breast implants failed to conduct post-approval clinical studies and received warning letters as a result. These include warning letters issued to Sientra, Inc of Santa Barbara, CA and Mentor Worldwide LLC & Acclarent (a subsidiary of Johnson & Johnson) of Irvine, CA. Here is the FDA press release.
DRUGS | United Exchange Corporation
United Exchange Corporation (Cypress, CA) received a warning letter on March 6, 2019 based on the outcome of the inspection of two facilities ending April 6, 2018. The firm relies on contract manufacturers and FDA reminds them that they “…remain responsible for the quality of their drugs ‘regardless of agreements in place with your contract facilities’.” FDA also suggests they retain a consultant to assist them to come into compliance with regulations.
The warning letter consists of a single three-part deficiency, including but not limited to:
- The firm provides inadequate oversight of its contract manufacturers. FDA stated that this “led to your use of multiple sub-standard contract manufacturers.” FDA also states “FDA has taken the following actions in response to CGMP violations found at your contract manufacturers.” They list six actions that are completely redacted.
- The firm did not perform final reviews of each batch to determine it’s disposition.
- The firm did not establish adequate procedures governing a variety of GMP areas.
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About the Author
Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
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