SpecGx LLCSeptember 22, 2025

FDA 483 - SpecGx LLC - September 22, 2025

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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.

Company: SpecGx LLC
Inspection Date: September 22, 2025
Product Type: Drugs
Office: Atlanta District Office
Person: Yvins Dezan

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ID · cdfca736-3419-4deb-b894-3fc47a3b540d