Centaur Pharmaceuticals Private Ltd. – FDA Warning Letter, Feb 8, 2023

On July 25, 2023, the FDA issued a Warning Letter to Centaur Pharmaceuticals Private Ltd. following an inspection from January 30 to February 8, 2023, at their Pune, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** The firm failed to properly clean non-dedicated equipment, including blenders and fluid bed dryers. Residues of different products, including active ingredients, were found on direct and indirect product contact surfaces. Some equipment sections had not been cleaned or examined for cleanliness in over 14 years. Missing or faulty gaskets and material backflow also contributed to contamination. This led to recalls of alprazolam and clobazam tablets. The firm's response, claiming no product quality impact based on limited testing, was deemed inadequate.

2. **Inadequate Quality Unit (QU) and Procedures (21 CFR 211.22(a) and (d)):** * **Inadequate Cleaning Procedures:** The QU failed to ensure cleaning procedures for blenders were sufficient, and visual inspection procedures failed to identify visible contamination. The firm's corrective actions lacked