FDA 483 - Kemwell Biopharma Private Limited - May 12, 2025

An FDA inspection of Kemwell Biopharma Private Ltd in Bengaluru, India, a contract manufacturer of human drugs, revealed significant deficiencies in quality control and sterility assurance. Observations included a lack of established acceptance criteria for visual inspection, inadequate audit trail review procedures, and critical failures in aseptic processing controls. These issues pose a high risk of microbiological contamination and compromise product sterility.