Cipla Limited – FDA 483, Aug 25, 2026

Cipla Limited, a sterile and non-sterile drug manufacturer in Pithampur, India, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies in complaint handling, aseptic processing controls, environmental monitoring, investigation of discrepancies, computer system controls, manufacturing process validation, and equipment cleaning procedures. These issues indicate a high risk of product contamination and quality control failures.