FDA posted a dozen warning letters and five advisory letters to companies illegally selling dietary supplements meant to treat or cure Alzheimer’s disease. This appears to be a shot across the bow regarding actions that FDA will be taking to improve the safety of dietary supplements. We cover four other warning letters here, including one to a drug manufacturer, one to a distributor, and two to medical device firms.
- DRUG: Samson Pharmaceuticals Inc., (Commerce, CA) received a warning letter on December 13, 2018 based on the outcome of an inspection ending February 9, 2018. FDA recommends the firm hire a GMP consultant(s) to assist them in coming into GMP compliance. The firm manufactures OTC products. Deficiencies include but are not limited to:
- Aseptic processing areas are not properly maintained; peeling paint was observed in wall surfaces. Also, the firm failed to establish alert and action levels for monitoring personnel.
- The firm performed only one media fill between 2015 and 2017 and also lacked smoke studies to demonstrate laminar air flow.
- The firm did not validate the sterility test method and demonstrate equivalence to the USP method.
- The firm failed to perform identity testing on incoming components but relied on the vendor CoA. This is particularly important because the firm did not test their glycerin for DEG or EG as hazardous impurities.
- The firm did not establish a long term room temperature stability study to support expiry dating on OTC products.
- DISTRIBUTOR: McKesson Corporation (San Francisco, CA) received a warning letter on February 7, 2019 based on the outcome of an inspection ending July 3, 2018. This is the first warning letter issued under authority granted to FDA in the DSCSA, and the letter cites section 582(c)(4) of the FD&C Act. Commissioner Gottlieb addressed the issue in a press release. Here is the form 483 that lead to the warning letter. Deficiencies include but are not limited to:
- “Your firm failed to respond to illegitimate product notifications as required, which includes identifying all illegitimate product subject to such notifications in your possession or control and quarantining such product (section 582(c)(4)(B)(iii)).
- Your firm failed to quarantine and investigate suspect product (section 582(c)(4)(A)(i)).
- Your firm failed to keep, for not less than 6 years, records of the investigation of suspect product and the disposition of illegitimate product (sections 582(c)(4)(A)(iii) and 582(c)(4)(B)(v)).”
The warning letter provides three detailed examples of McKesson’s failures. FDA also addresses the inadequacy of McKesson’s proposed corrective actions. The warning letter should be required reading for all medicinal product distributors. Hopefully, this will get their undivided attention. FDAzilla published a more detailed post on the topic.
- DEVICE: LC Medical Concepts, Inc (Rochester, NY) received a warning letter based on the outcome of an inspection ending October 23, 2018. The firm makes negative pressure wound therapy kits. Deficiencies include but are not limited to:
- The firm moved manufacturing operations from one facility to another with different manufacturing conditions. Further, periodic dose audits have not been conducted on the sterilization process.
- The firm did not follow their own sampling plan.
- Failure to periodically calibrate equipment.
- Failure to verify effectiveness of CAPA actions and ensure they did not have unintended negative consequences.
- DEVICE: Circulatory Technology Inc (Oyster Bay, NY) received a warning letter based on the outcome of an inspection ending September 16, 2018. The firm makes bladder devices. Deficiencies include but are not limited to:
- The firm did not revalidate the manufacturing process when changes were made.
- The firm had continued design deficiencies that had been discussed with the FDA in November 2017.
- The complaints received by the firm did not include adequate information to determine whether they needed to be reported to FDA. The firm did not make changes to ensure that they received adequate information about complaints.
- The firm did not adequately document all CAPAs.
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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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