Enforcement:
- Recalls:
- 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
- 483s:
- 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.