Week of December 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.  We cover these three below:


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  • Zhejiang Huahai Pharmaceutical (Zhejiang, China) received a warning letter on November 29, 2018 based on the outcome of an inspection ending August 13, 2018.  This is unusually quick for a warning letter to issue. This is one of the firms that manufacture the valsartan API that has been used in a collection of drug products recalled over the past few months.  They were placed on import alert on September 28, 2018. FDA recommends they hire qualified consultants to assist them in coming into GMP compliance. Deficiencies include but are not limited to:
    • Investigation into an unknown peak, later identified as NDMA, was deficient.
    • The firm failed to evaluate potential effect of a change in the manufacturing process.  The process change made in 2011 (no, not a typo) is responsible for the NDMA contaminant introduction.
  • Skylark CMC Pvt. Ltd., (Ahmedabad, Gujarat, India) received a warning letter on December 3, 2018 based on the outcome of an inspection ending June 25, 2018.  The firm barred access to the manufacturing area of the facility, and failed to provide records when requested.  Further, FDA conducted an unannounced inspection of your facility because research indicated it has the same physical address as Vikshara Trading & Investments Ltd. (FEI 3004982352), a firm that is currently on FDA Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection.”   The current firm was placed on import alert on November 8, 2018.
  • Compounding Pharmacy Warning Letter: Hybrid Pharma LLC (Deerfield Beach FL) received a warning letter on November 30, 2018 based on the outcome of an inspection ending July 28, 2016 (also not a typo).


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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.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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