Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of
WHO has issued an alert on falsified Propylene glycol bearing name of Dow detected in
The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by
J&Js paediatric cough syrup Benylin is being recalled in several African countries following detection of
The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of
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,
Natco Pharma is recalling one more lot of Lanzoprazole 15 mg delayed release capsules for
