FDA 483 - Cipla Limited - February 17, 2023

An FDA inspection of Cipla Limited in Pithampur, India, revealed significant deficiencies across multiple systems, including failures in aseptic processing, environmental monitoring, data integrity, and quality control. The firm failed to thoroughly investigate discrepancies, maintain sterile conditions, control computer systems, and adequately handle numerous patient complaints and field alert reports. These issues indicate a systemic lack of adherence to cGMP regulations for both sterile and non-sterile drug manufacturing.