Warning letters, 483s, Recalls, Import Alerts, Audit observations
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim
