Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Government of India has published a draft notification proposing an amendment to the Drugs
The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025,
The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated
An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva
Biosimilarity CAA more sensitive than CES The USFDA has published a draft guidance updating scientific
Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO) has issued new directions for stringent
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
