Warning letters, 483s, Recalls, Import Alerts, Audit observations
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The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products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
USFDA has launched a new search page for Quality documents. The page provides useful links
This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration
Due to an incident of “foreign capsule” in the bottle, Dr.Reddy’s initiated a voluntary recall
