FDA 483 - PolyPeptide Laboratories Private Limited - November 22, 2024

An FDA inspection of PolyPeptide Laboratories Private Limited, an API manufacturer in Ambernath, India, revealed significant deficiencies in the firm's Quality Unit. Observations included inadequate supplier qualification for packaging materials and a failure to timely close multiple deviation investigations according to established procedures. These issues indicate a lack of robust quality control over critical manufacturing processes and documentation.