Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has issued a new guidance for primary batches to be included in the CMC
FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic
Dublin based Par Pharmaceutical, part of Endo International plc is recalling one lot of Treprostinil
Eugia US LLC is recalling three lots of Methylprednisolone acetate Injectable Suspension (80mg/mL, 5mL Multiple-Dose
Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA
FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)
Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
