Warning letters, 483s, Recalls, Import Alerts, Audit observations
Recent USFDA warning letter, issued to Baxter (October 2026), citing inadequate beta lactam contamination controls
Baxter International Inc, was issued an FDA Warning Letter following cGMP violations observed during an
The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
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
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of
