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


  • 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


Get the complete warning letter & 483 details
with our GMP Newsletter free trial.


  • 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.


Like this & want more?
Sign up to get free weekly content updates
designed to make your job easier


Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspectorProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

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

Like this post? Don't forget to share it!

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
Govzilla Bug

Don’t miss out! Subscribe now

Experience the Power of Govzilla

Get your FREE account to search sites, inspections, & warning letters