FDA/GMP Updates | August 2018

Last month’s GMP Regulatory Intelligence Newsletter scans consisted mostly of just the bare essentials since I’ve been on vacation in Washington state doing a LOT of wonderful hiking with very little connectivity. This month will be back to normal…without the stunning scenery and hiking.

Happy Reading,


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Laws, Regulations, Guidance, and Concept Papers


  • FDA published 10 warning letters for drug product sites + 1 GLP site + 1 device firm. Of those issued to drug sites:
    • 4 of those were OTC (and continue FDA’s focus on this market segment)
    • 1 manufactures homeopathic products
    • 1 manufactures solid oral drug products
  • Some recalls, a variety of import alerts (including refusal of FDA inspections), and 1 safety alert.
    • We are going to continue to see recalls of Valsartan products for a while as additional products are identified as being contaminated.


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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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