Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA issues Guidance on Container Closure

The USFDA has released a new draft guidance, Container Closure Systems for Human Drugs and

Venkitesh TK
August 24, 2026

FDA Warning Letter to Viatris: Concerns

FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning

Venkitesh TK
January 1, 2025