Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
USFDA has launched a new search page for Quality documents. The page provides useful links
The letter to FDA was written by the Republican members of the E&C committee of
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
FDA approves Evive Biotech’s Ryzneuta for the management of chemotherapy-induced neutropenia (incidence of infection, as
Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI
