DETAILS OF WARNING LETTER ISSUED TO

GLENMARK

NMARK'S PITHAMPUR UNIT, PLANT INSPECTED FROM FEB 3-14, 2025

➝ Facility's methods, facilities, and controls do not meet cGMP standards. ➝ Failed to adequately investigate dissolution failures in KCL ER capsules and another product. ➝ Investigations lacked sufficient scientific evidence. ➝ Delayed stability testing led to late detection of product failures and delayed recalls, field alerts. ➝ FDA cited cGMP violations at the company's facilities in Himachal Pradesh, Goa, and North Carolina. ➝ Repeated violations at multiple sites indicate that management oversight and control are inadequate. ➝ FDA recommends engaging a cGMP consultant and conducting a comprehensive global quality system review.