Curia New York, Inc. – FDA 483, Nov 1, 2023

Curia New York, Inc. in Rensselaer, NY, an API manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to maintain adequate cleanliness in critical areas, including a walk-in cooler storing raw materials and laboratory balance enclosures. Additionally, the Quality Unit did not timely review and approve complaint investigations according to their own procedures.