- Classified recalls from 21 firms, Unclassified recalls from 13 firms
- Class II and III recalls
- Import Alerts:
- 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
- 3 483s sent, one to a Phizer Inc (Hospira) site
- Consent Decree Agreement: none
- Europe Published:
- French authorities issued a statement of non-compliance with GMPs to Kores (India) Limited
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 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