Warning letters, 483s, Recalls, Import Alerts, Audit observations
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
In a Class 3 recall Teva initiated recall of one lot each of Nortrel and Nortrel
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Natco Pharma initiated a recall of one lot of Lanzoprazole 15mg capsules in US. Reason
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
