Warning letters, 483s, Recalls, Import Alerts, Audit observations
Granules India received a warning letter from the USFDA in February 2025. This was along
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical
Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in
Authored by: Srinivas Churya In the pharmaceutical industry, analytical division and analytical laboratories plays a
Five different facilities of Eugia across India and US were inspected by USFDA between December
The Eugia facility in Bhiwadi, Rajasthan, India (FEI 3009883410) was recently classified as OAI (Official
Biocon Visakh (Biocon Biosphere Limited, FEI 30221 25340) was inspected by USFDA investigator Brandy N
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
Dr.Reddys Laboratories (DRL) has initiated recall of one lot of Allopurinol Tablets, USP 300mg in
Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer
