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

Source: https://www.keypedia.com/records/483/ergomed-inc/42f86d4e-6e8f-423c-b546-700f847c704b

> FDA 483 for ErgoMed, Inc. on December 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ErgoMed, Inc.
- Inspection Date: 2023-12-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Documents

- [483 - 2021-11-05](https://www.keypedia.com/records/483/ergomed-inc/bdfb065c-ba3c-416b-83ef-e3cfe4b1eccc)
- [483 - 2022-10-05](https://www.keypedia.com/records/483/ergomed-inc/0b7f1b4c-511e-46fe-ae3b-460d897bab6b)

## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.keypedia.com/companies/ergomed-inc/5e741b64-904e-40af-a99e-beaee2784b70

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab