FDA 483 - Western New York Energy, LLC - November 08, 2022

An FDA inspection of Western New York Energy, LLC. in Medina, New York, an API manufacturer of 200 Proof Ethanol, revealed significant deficiencies in good manufacturing practices. The firm failed to ensure proper testing and release of its ethanol, lacked an effective quality unit, and exhibited inadequate control over facilities, equipment, and personnel training. These issues indicate a systemic failure to meet regulatory standards for drug substance manufacturing.