Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 to Pharmathen Flags Deficient

USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form

Qvents
February 5, 2026

FDA Warning Letter to Indoco Remedies Fl

Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical

Qvents
January 10, 2025

USFDA Warning letters, 483s, WHO Alerts

Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality

Qvents
May 10, 2023