FDA 483 - Pharmalogic New York City, LLC - January 12, 2024

An FDA inspection of Pharmalogic New York City, LLC, a PET manufacturer, revealed a significant deficiency in personnel training. The firm's on-site employees had not completed required training for the manufacture, testing, stability evaluation, and release of a specific NDA product. This indicates a serious lapse in quality system controls related to personnel qualifications.