FDA EIR - ErgoMed, Inc. - August 23, 2019

An FDA inspection of ErgoMed, Inc., a medical device manufacturer in San Antonio, TX, was conducted on August 23, 2019. The inspection, performed under the Quality System Regulation (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) frameworks, identified multiple significant deficiencies. The agency issued a five-item FDA Form 483.

Key violations included the absence of established procedures for complaint handling, purchasing controls, corrective and preventive actions (CAPA), and quality audits. Specifically, ErgoMed failed to implement written processes for receiving and evaluating product complaints, documenting supplier evaluations for their contract manufacturers, and defining comprehensive CAPA and internal audit systems. Additionally, the firm's written Medical Device Reporting (MDR) procedure was deemed inadequate, lacking essential definitions and timelines for timely reporting, and no eSubmitter account was established for electronic submissions.

The inspection also revealed that ErgoMed, which develops and distributes Class I medical devices, was not adequately registered with the FDA, and its devices were not listed. Management also lacked a formal Quality Manual and documented training procedures. ErgoMed's CEO acknowledged the observations and committed to submitting a written response to the FDA within 15 business days, with a promise to correct the deficiencies within 90 days. The agency indicated potential legal sanctions if conditions are not voluntarily corrected.