Warning letters, 483s, Recalls, Import Alerts, Audit observations
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Natco Pharma initiated a recall of one lot of Lanzoprazole 15mg capsules in US. Reason
Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed
USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance
The USFDA announced next phase of the Quality Management Maturity (QMM) Program for drug manufacturers.
Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation
The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
Dr Reddys (DRL) initiated recall of one batch of Tizanidine 4mg tablets in US in
Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding
