Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations
Dr.Reddys Laboratories (DRL) has initiated recall of one lot of Allopurinol Tablets, USP 300mg in
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer
Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA
The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals
USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
