Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Warning Letter to Simtra Biopharma F

The U.S. FDA has issued a Warning Letter to Simtra BioPharma Solutions following cGMP deviations

Qvents
April 10, 2026

FDA 483 to Favera, France Cites Gaps in

FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva

Qvents Team
December 10, 2025