FDA 483 - Ear Technology Corporation - May 24, 2022

An FDA inspection of Ear Technology Corporation in Johnson City, TN, a specification developer, revealed significant deficiencies in their quality management system. The firm lacked adequate procedures for complaint handling, supplier control, finished device acceptance, device history records, rework, and quality audits for their AllClean UV-C device. These issues indicate a systemic failure to establish and maintain essential quality system procedures.