Just Issued Recalls, 483s, Laws, & Warning Letters | December 2018

Enforcement:

  • Recalls:
    • Classified recalls from 21 firms, Unclassified recalls from 13 firms
    • Class II and III recalls
  • Import Alerts:
    • A limited number of import alerts from Israel and China

 

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  • Warning Letters:
    • Drug Manufacturers:  4 warning letters
    • Human Cells/Tissues: 2 warning letters
    • Compounding Pharmacies:  1 warning letter for an inspection ending in 2016 (not a typo)
    • Device Firms: 1 warning letter
  • 483s:
  • Consent Decree Agreement: none
  • Europe Published:

Laws & Guidance:

  • Guidance: The FDA, EMA, TGA, HPRA and WHO all published guidance, including 17 from the FDA and 4 from the EMA.
  • Non-Guidance: Numerous publications this month from the FDA, EMA, MHRA, HPRA, and Health Canada.

 

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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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