Warning letters, 483s, Recalls, Import Alerts, Audit observations
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Biosimilarity CAA more sensitive than CES The USFDA has published a draft guidance updating scientific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
Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in
Spurious Drug – Toxic DEG Contamination Reports of child deaths linked to contaminated cough syrups
Amid all the ongoing Tariff Turf War, the U.S. Food and Drug Administration (FDA) has
