FDA 483 - Edge Pharma, LLC - November 30, 2021

Edge Pharma, LLC, an outsourcing facility in Colchester, VT, was cited with 13 observations during an FDA inspection from September to November 2021. The inspection revealed significant deficiencies across multiple areas, including facility maintenance, environmental control, quality control unit procedures, and investigation practices for discrepancies, OOS results, and customer complaints. These issues indicate a systemic failure to maintain a state of control and ensure the quality and sterility of drug products.