Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Strides FDA 483 Flags Lapses in Microbio

The USFDA issued a Form 483 to Strides Pharma Sciences Ltd., Bangalore facility (FEI 3004554612)

Aurobindo’s Eugia Facility Classified

Aurobindo’s Eugia Pharma Specialities Limited (FEI 3011960448), located at Shameerpet, India, has been classified OAI

FDA Warning Letter to Simtra Biopharma F

The U.S. FDA has issued a Warning Letter to Simtra BioPharma Solutions following cGMP deviations

FDA Publishes Warning Letter with Photos

The USFDA has issued a Warning Letter to the Indian drug manufacturing facility of Patcos

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