Warning letters, 483s, Recalls, Import Alerts, Audit observations
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities
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 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
