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

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

Enforcement:

  • Recalls:
    • A handful of both classified and unclassified
      • Among the unclassified recalls are additional recalls of Valsartan-like APIs. Seems like this will be going on for a while!
    • Class II and III recalls
  • Import Alerts:

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Laws & Guidance:

  • Guidance | The HPRA, EMA, Health Canada, CDSCO, TGA, and WHO all published guidance including:
    • 17 from the FDA with:
      • 3 focusing on generic drugs
      • 2 addressing requirements for transdermal patches
    • EMA published:
  • The EMA, MHRA, TGA, HPRA, CDSCO, and FDA all published non-guidance.

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About the Author

Barbara W. Unger

Barbara W. Unger 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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