Novan, Inc. – FDA 483

Novan, Inc. in Durham, NC, an Intermediate and API Manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures to thoroughly investigate unexplained discrepancies and out-of-specification results, inadequate control procedures for manufacturing processes, and a lack of proper validation and monitoring of component and contract laboratory suppliers. These issues indicate a need for improved quality control and supplier management systems.