Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
The letter to FDA was written by the Republican members of the E&C committee of
China’s revision of counter espionage laws in April 2023, with enumeration of espionage activities extended
The GMP/GDP Inspectors Working Group coordinated by EMA has decided to continue the extension of
The European Commission has published the first Union list of critical medicines, together with the
