# FDA 483 - Arch Medical Solutions - Elkhart - December 18, 2024

Source: https://www.globalkeysolutions.net/records/483/arch-medical-solutions-elkhart/b302bb56-b2c0-4739-9f0b-462dfdb6a9d2

> FDA 483 for Arch Medical Solutions - Elkhart on December 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arch Medical Solutions - Elkhart
- Inspection Date: 2024-12-18
- Product Type: device
- Office Name: Detroit District Office
- Summary: Arch Medical Solutions - Elkhart received a Form FDA 483 with four observations related to deficiencies in their quality system. The inspection revealed issues with controlling nonconforming product, inadequate rationale for "use-as-is" dispositions, and a failure to evaluate changes to a validated process. Additionally, the firm's complaint handling procedures were found to be inadequate, with undocumented investigations and inconsistent documentation methods.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/arch-medical-solutions-elkhart/83ada101-3f4d-4244-8dd3-a4eda3144b44

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03