FDA published the fiscal year FY 2024 GD
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
Failure to thoroughly review unexplained discrepancies. Out of specification results on multiple batches of tablets
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim