Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
MHRA has decided to continue the extension of the validity GMP & GDP Certificates until
The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene
Baxter recalled several lots of Ondansetron injections in US for pH failure in November 2023.
FDA has approved Novartis’ Iptacopan (Fabhalta) for treatment of rare blood disease, Paroxysmal Nocturnal Hemoglobinuria
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
Dr.Reddys Laboratories (DRL) Medchal, Telengana site was inspected by USFDA (Investigators Saleem A Akhtar &
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
