483
CTX Lifesciences Private LimitedFDA 483 - CTX Lifesciences Private Limited - September 02, 2022
Record Details
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.
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ID · 90a131a0-92b6-4343-8a31-2a5bfabaf26c