483
Kemwell Biopharma Private LimitedKemwell Biopharma Private Limited – FDA 483, May 12, 2025
Record Details
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.
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