Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA
