Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a Form 483 to Strides Pharma Sciences Ltd., Bangalore facility (FEI 3004554612)
The USFDA recently issued a warning letter to Intas Pharmaceuticals Limited (Dehradun facility, FEI 3005890633
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Qvent post discusses the Regulatory guidances and Requirements for Electronic data controls and review, Data
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at
