FDA 483 - CTX Lifesciences Private Ltd. - September 02, 2022

An FDA inspection of CTX Lifesciences Private Limited in Surat, Gujarat, India, revealed significant deficiencies in the manufacturing of Active Pharmaceutical Ingredients (APIs). The firm's quality unit failed to ensure CGMP compliance, with issues spanning process and cleaning validation, discrepancy investigations, and data integrity. These observations indicate a lack of adequate controls and oversight in critical manufacturing and quality assurance processes.