# FDA 483 - ARCH Medical Solutions - Warsaw - December 04, 2024

Source: https://www.globalkeysolutions.net/records/483/arch-medical-solutions-warsaw/e2777c3c-6798-4e94-be6b-83ca7799ce30

> FDA 483 for ARCH Medical Solutions - Warsaw on December 04, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARCH Medical Solutions - Warsaw
- Inspection Date: 2024-12-04
- Product Type: device
- Office Name: Detroit District Office
- Summary: An inspection of ARCH Medical Solutions - Warsaw revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for controlling nonconforming product, including dispositioning, rework, and scrap. Additionally, acceptance activities were not consistently documented, and procedures for routine equipment calibration were found to be inadequate.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/arch-medical-solutions-warsaw/6155c0e7-ca20-4fd7-bfc7-5cd439af7f76

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