FDA EIR - Avadim Holdings Inc - November 04, 2016

A routine FDA inspection of Avadim Technologies Inc., a company formulating, selling, and distributing Over-the-Counter (OTC) drug topical products, was conducted from November 1-4, 2016. The inspection identified five significant observations, several of which were repeat issues from a prior inspection of the predecessor entity, Avadim, LLC.

Main violations included the absence of written procedures for production and process controls designed to assure drug product identity, strength, quality, and purity, particularly concerning finished product testing. The quality control unit demonstrated inadequate adherence to its responsibilities, evidenced by incomplete deviation and customer complaint documentation, a lack of scientific rationale for root cause investigations, improper labeling of released products, and insufficient review of contract manufacturer records, leading to the approval of products made with expired components. Outdated marketing materials were also commingled with current ones.

Further issues involved the lack of a formal written program to assess drug product stability, hindering proper expiration date determination. Procedures to prevent objectionable microorganisms in non-sterile drug products were not established, including validation of bioburden reduction and a written program for microbial testing. Finally, the company lacked established procedures for warehousing drug products, evidenced by uncontrolled temperature in sample storage and facility deficiencies.

These observations indicated non-compliance with regulatory requirements, primarily under Current Good Manufacturing Practice (21 CFR Part 211). Avadim Technologies Inc. was instructed to submit a formal response to the FDA's findings within 15 working days.