Warning letters, 483s, Recalls, Import Alerts, Audit observations
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form
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
Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations
Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA
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
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
Laurus, Visakh (India) was issued USFDA 483 with five (5) observations following USFDA inspection by
