Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Sun Pharma Baska Facility Classified OAI

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

USFDA 483 to Catalent Baltimore Flags De

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

FDA 483 to Favera, France Cites Gaps in

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

OAI Classification for Sun Pharma Halol

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

FDA 483 to Catalent Indiana Flags Inadeq

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

Natco Pharma USFDA 483 Flags Deficiencie

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

Janssen’s Korea Vaccine Unit USFDA 483

Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical

FDA Warning Letter to Indoco Remedies Fl

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

USFDA Issues Warning Letter to Zydus: Fl

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,

Eugia Bhiwadi Facility Classified OAI: W

The Eugia facility in Bhiwadi, Rajasthan, India (FEI 3009883410) was recently classified as OAI (Official