Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection
In May 2023, Sun Pharma initiated recall of two lots of antidepressant drug Bupropion Hydrochloride
