FDA 483 - ErgoMed, Inc. - October 05, 2022

An FDA inspection of ErgoMed, Inc. in San Antonio, TX, a specification developer of Class I non-sterile tracheal tube fixation and anti-disconnect medical devices, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for supplier controls, acceptance activities, nonconforming product, medical device reporting, quality audits, and document control. Notably, the lack of quality audit and document control procedures were repeat observations from previous inspections, indicating persistent issues.