FDA EIR - Avadim Holdings Inc - March 06, 2019

An FDA surveillance inspection of Avadim Health Inc., a non-sterile liquid contract manufacturer of over-the-counter topical drugs, was conducted from March 4-6, 2019, in Asheville, NC. The inspection, carried out under Compliance Program 7356.002 for Drug Manufacturing, primarily covered the Quality, Facilities, and limited Laboratory Systems. Unlike the previous inspection in 2016 which resulted in five observations regarding procedures for production and process controls, quality unit responsibilities, stability testing, prevention of objectionable microorganisms, and warehousing, the current inspection did not issue a Form FDA 483. All previous observations were confirmed to have been adequately addressed.

The sole issue identified during this inspection was a verbal observation concerning an employee performing deviation investigations without complete formal training as required by the firm's training matrix. Avadim Health Inc. management committed to completing the necessary training for the employee before assigning further independent tasks in untrained areas. Additionally, the firm was advised to update its recall procedure SOP to accurately reflect the correct individual responsible for investigations. The company is registered with the FDA and operates under a comprehensive quality agreement with its manufacturing subsidiary, Relion Manufacturing, Inc.