FDA 483 - Curia New York, Inc. - May 18, 2015

AMRI Rensselaer Inc. in Rensselaer, NY, an API manufacturer, was cited for five observations during an FDA inspection from May 18-22, 2015. The inspection revealed significant issues related to material storage conditions, deviation investigations, sample labeling, and equipment calibration, indicating a lack of adherence to established procedures and quality control.