FDA 483 - ErgoMed, Inc. - December 06, 2023

An FDA inspection of ErgoMed, Inc. in San Antonio, TX, a specification developer of medical devices, revealed significant deficiencies primarily related to Unique Device Identification (UDI) requirements and complaint handling. The firm failed to apply UDIs to its Class I endotracheal tube securing and vent anti-disconnector devices and did not submit required device identifiers to the Global Unique Device Identification Database (GUDID). Additionally, customer complaint files were not adequately maintained, specifically lacking evaluation for Medical Device Reporting (MDR) reportability.