Warning letters, 483s, Recalls, Import Alerts, Audit observations
Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in
FDA conducted an inspection at the Hetero Labs Ltd, Warehouse at Nakkapally Village, Vishakapatnam, Andra
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance
USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven
