Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA inspected Granules India’s Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad
Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.
Five different facilities of Eugia across India and US were inspected by USFDA between December
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
