Warning letters, 483s, Recalls, Import Alerts, Audit observations
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 –
Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential
FDA has updated MAPP for assessment of requests for reclassification of facility-based major complete response
