Shilpa Medicare Limited – FDA 483, Nov 9, 2023

Shilpa Medicare Limited, a drug product manufacturer in Pollenpally, Telangana, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. Observations included inadequate component testing, failures in OOS investigations, deficient aseptic processing and cleaning, incomplete process validation, and poor data integrity practices. These issues indicate a systemic lack of adherence to cGMP regulations, posing a risk to drug product quality and sterility.