# FDA 483 - Novan, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/novan-inc/7f44e7b5-23f6-43df-8c36-867b8e9f0263

> FDA 483 for Novan, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novan, Inc.
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Susan O. Oladeji](https://www.globalkeysolutions.net/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.globalkeysolutions.net/companies/novan-inc/eaeec299-1273-4f45-9b5c-0340e948c742

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7