FDA 483 - Shilpa Medicare Limited

The FDA inspection of Shilpa Medicare Limited revealed significant deficiencies across multiple areas, including a failing Quality Unit that inadequately classified complaints and OOS results, and a lack of effective CAPAs. The firm demonstrated poor control over sterile and non-sterile drug product manufacturing, with issues in process validation, aseptic processing, environmental monitoring, and laboratory controls. Additionally, the company failed to maintain proper instrument calibration, ensure data integrity, manage reserve samples correctly, and submit timely Field Alert Reports, indicating systemic quality and compliance breakdowns.