# FDA 483 - Sodium Systems LLC - October 22, 2025

Source: https://www.globalkeysolutions.net/records/483/sodium-systems-llc/d40bf237-5737-4ffc-b658-c2e74d2cc8c1

> FDA 483 for Sodium Systems LLC on October 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sodium Systems LLC
- Inspection Date: 2025-10-22
- Product Type: device
- Office Name: Detroit District Office
- Summary: Sodium Systems LLC, a medical device manufacturer in Ann Arbor, MI, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in supplier qualification, design validation, device history records, complaint handling, and unique device identification marking for reusable devices. These issues indicate a need for comprehensive improvements in their quality system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.globalkeysolutions.net/companies/sodium-systems-llc/639b70ca-50be-4de5-94e8-1496f322e2c7

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