Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA
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
USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
