FDA WARNING_LETTER - CTX Lifesciences Private Ltd. - February 16, 2019

On July 12, 2019, the FDA issued a Warning Letter to CTX Lifesciences Private Ltd. following an inspection from February 11-16, 2019, at their Surat, Gujarat, India facility. The letter identifies significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to monitor and control water quality for non-sterile API intended for sterile drug products:** The firm did not monitor water used in rinse steps for endotoxins, despite the API being for sterile injectable drug product manufacturing. This violates ICH Q7 expectations. 2. **Inadequate investigation of out-of-specification (OOS) results:** The firm invalidated an OOS related substances test result for API (b)(4) batch (b)(4) without sufficient scientific justification. Their investigation attributed the OOS to sonication during sample preparation, but failed to investigate all potential causes, including manufacturing operations, despite similar issues in past inspections.

The FDA requires a response within 15 working days detailing corrective actions, including a thorough review of production for OOS results with inconclusive lab root causes, a CAPA plan for investigation competencies, root cause analysis, procedures, quality unit oversight, and CAPA effectiveness evaluation. The firm must