Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an
Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer
Dublin based Par Pharmaceutical, part of Endo International plc is recalling one lot of Treprostinil
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in
