Warning letters, 483s, Recalls, Import Alerts, Audit observations
The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products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
FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)
Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec
USFDA inspected Laurus Synthesis, Visakh facility in India (FEI: 3011524794) in Dec 2023 by investigators
FDA has published a revised guidance on quality considerations for topical ophthalmic drug products –
