Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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.

IPCA unit at Dhar, Madhya Pradesh, India

Failure to thoroughly review unexplained discrepancies. Out of specification results on multiple batches of tablets

USFDA 483 / IPCA / June 2023 /Failure of

USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim