FDA WARNING_LETTER - Centaur Pharmaceuticals Private Ltd. - November 21, 2022

On June 5, 2023, the FDA issued a Warning Letter to Centaur Pharmaceuticals Private Ltd. following an inspection from November 14-21, 2022, at their Thane, Maharashtra, India facility. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API), rendering their API adulterated under the FD&C Act.

Key violations include: 1. **Failure of the Quality Unit (QU) to ensure CGMP compliance:** * Inadequate document control over paper and electronic records, including the creation of "uncontrolled documents" and destruction of CGMP documents without proper controls. The firm also assigned multiple CGMP documents the same control number. * Failure to ensure materials are appropriately tested and results reported, exemplified by unlabeled HPLC vials compromising data reliability. The firm's response regarding SOP revisions and training was deemed inadequate for not determining the scope or root cause. 2. **Failure to adequately clean equipment and utensils:** * Manufacturing equipment labeled "Cleaned" was found with deficiencies, specifically peeling (b)(4) material in a (b)(4)-303. The firm's response was inadequate for not evaluating the risk on all APIs or providing a root cause analysis.

The FDA requires a written response within 15 working days detailing corrective actions, recurrence prevention, and a completion schedule. Failure to comply may result in withheld