FDA 483 - Novan, Inc.

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.