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

Source: https://www.keypedia.com/records/483/ergomed-inc/0b7f1b4c-511e-46fe-ae3b-460d897bab6b

> FDA 483 for ErgoMed, Inc. on October 05, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ErgoMed, Inc.
- Inspection Date: 2022-10-05
- 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 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.

## Related Documents

- [483 - 2021-11-05](https://www.keypedia.com/records/483/ergomed-inc/bdfb065c-ba3c-416b-83ef-e3cfe4b1eccc)
- [483 - 2023-12-06](https://www.keypedia.com/records/483/ergomed-inc/42f86d4e-6e8f-423c-b546-700f847c704b)

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

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