FDA 483 - Chartwell Pharmaceuticals Carmel LLC - October 06, 2022

An FDA inspection of Chartwell Pharmaceuticals Carmel LLC in Carmel, NY, from September 28 to October 6, 2022, revealed significant deficiencies in their quality system. Findings included inadequate review of GMP procedures, lack of proper equipment cleaning validation, insufficient computer system controls, and inaccurate yield calculations. Additionally, the firm failed to maintain appropriate drug product storage conditions and prevent contamination in manufacturing areas.