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

FDA Classifies Novo Nordisk Plant OAI, P

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

Hetero Warehouse Flagged for Serious Lap

FDA conducted an inspection at the Hetero Labs Ltd, Warehouse at Nakkapally Village, Vishakapatnam, Andra

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

USFDA 483 for Glenmark Facility Highligh

USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations

USFDA 483 to Novo Nordisk Cite Lapses in

FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at

Deficient Method Validations, Aseptic ar

Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance