FDA 483 - ErgoMed, Inc. - November 05, 2021

ErgoMed, Inc. in San Antonio, TX, a specification developer, was cited with six observations during an FDA inspection from November 3-5, 2021. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for complaints, CAPA, purchasing controls, quality audits, MDRs, and document control. Many of these issues were repeat observations from a previous inspection in 2019, indicating a persistent failure to implement adequate quality management systems.