FDA WARNING_LETTER - Centrient Pharmaceuticals India Private Limited - July 01, 2022

The FDA issued a Warning Letter to Centrient Pharmaceuticals India Private Limited following an inspection from June 23 to July 1, 2022, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure of the quality unit to ensure CGMP compliance:** Inadequate document control (uncontrolled logbooks, shredded documents, handwritten login credentials for computerized systems) compromised data integrity. The company's response was deemed insufficient, lacking a comprehensive retrospective risk assessment and detailed plan for future compliance. 2. **Failure to ensure scientifically sound and appropriate test procedures:** Inadequate validation of beta-lactam environmental monitoring methods and failure to follow established swab collection procedures. The method for detecting penicillin in non-beta-lactam buildings was not sufficiently sensitive. 3. **Failure to establish and follow written procedures for investigating critical deviations:** Inadequate investigation into black particles in API batches, lacking supporting data and comprehensive CAPAs for non-metallic and metallic contamination sources.

The FDA recommends engaging a qualified CGMP consultant to audit operations and assist in meeting requirements. The company was placed on Import Alert 66-40 on November 21, 2022. Corrective actions and a written response within 15 working days are required, detailing remediation plans, including comprehensive assessments of the quality unit, documentation systems, computer system security, laboratory practices, containment