Qvents

Qvents

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

Sun Pharma Baska Facility Classified OAI

The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated

Laboratory Incidents and Validation Fail

In November 2025, the USFDA issued a Warning Letter to Bangalore-based Cdymax India following an

FDA Classifies Novo Nordisk Plant OAI, P

Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in

Metallic Particles in APIs, Complaint In

The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The

OAI Classification for Sun Pharma Halol

In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official

Amneal Warning Letter Cites Fibers in PP

The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an

FDA 483 to Catalent Indiana Flags Inadeq

Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June

FDA Issues Repeat Warning Letter to Thai

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with