FDA 483 - SpecGx LLC - September 22, 2025

An FDA inspection of SpecGNX LLC in Raleigh, NC, an API manufacturer, revealed significant deficiencies in equipment cleaning and maintenance, air filtration systems, and overall facility upkeep, including pest control issues. The firm also failed to adequately investigate discrepancies, validate testing methods, and maintain effective quality unit procedures and laboratory controls, indicating systemic breakdowns in their quality management system.