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

USFDA 483 to Catalent Baltimore Flags De

An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor

Malta Medicines Authority Maintains cGMP

Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in

Natco Pharma USFDA 483 Flags Deficiencie

Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA

FDA Issues Warning Letter to Aspen Bioph

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs

Sanofi’s API Facility in US Issued

The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,

FDA Warning Letter to Indoco Remedies Fl

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

Eudra GMDP lists Everest Organics and Ak

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend

USFDA 483 to Sun Pharma points to lack o

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by

Warning letter to Jordans Amman Pharma:

FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)