Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Warning letter to Glenmark Facility at Pithampur (FEI 3008565058), cited cGMP violations at multiple
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
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
SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination
SCYNEXIS issued the recall of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to Potential for
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA
