CTX Lifesciences Private Limited – FDA 483, Sep 2, 2022

CTX Lifesciences Private Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Surat, India, received a Form 483 for significant deficiencies in its quality system. The inspection revealed failures in process and cleaning validations, inadequate review of discrepancies, poor computer system controls, and issues with equipment design, cleaning, and batch record keeping. These findings indicate a lack of adherence to Current Good Manufacturing Practices (CGMP) for API production.