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

Source: https://www.keypedia.com/records/483/ergomed-inc/bdfb065c-ba3c-416b-83ef-e3cfe4b1eccc

> FDA 483 for ErgoMed, Inc. on November 05, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ErgoMed, Inc.
- Inspection Date: 2021-11-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Documents

- [483 - 2022-10-05](https://www.keypedia.com/records/483/ergomed-inc/0b7f1b4c-511e-46fe-ae3b-460d897bab6b)
- [483 - 2023-12-06](https://www.keypedia.com/records/483/ergomed-inc/42f86d4e-6e8f-423c-b546-700f847c704b)

## Related Officers

- [Ellen J. Tave](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

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