FDA 483 - Avadim Holdings Inc - May 22, 2025

Avadim Holdings Inc, an OTC and Homeopathic Drug Manufacturer in Swannanoa, NC, received a Form 483 with three observations. The inspection revealed deficiencies in laboratory controls, including inadequate monitoring and testing of the water system, and a lack of scientifically sound specifications. Additionally, the firm failed to establish adequate production and process controls, specifically regarding cleaning validation for equipment and test method verification. Finally, the company's procedures for handling drug product complaints were found to be deficient and not followed, leading to delayed investigations.