Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary
Glenmark has initiated a recall of one lot of Diltiazem Hydrochloride 120mg, Extended Release(ER) Capsules
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC
