Pharmalogic New York City, LLC – FDA 483, Aug 19, 2026

An FDA inspection of Pharmalogic New York City, LLC, a PET drug manufacturer in Bronx, NY, revealed a significant deficiency in the firm's corrective action procedures. The company failed to take appropriate corrective actions for out-of-specification results from Bacterial Endotoxin Tests and environmental/personnel monitoring, often attributing failures to unconfirmed laboratory errors or concluding no impact without establishing root causes. This indicates a systemic issue in their quality control and investigation processes.