FDA Inspection 1288174 — Sodium Systems LLC
The FDA completed an inspection of Sodium Systems LLC on Oct 22, 2025 in Ann Arbor, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 22, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 22797 | 21 CFR 801.45(a) | Devices that must be directly marked with a unique device identifier |
| 3159 | 21 CFR 820.184 | DHR content |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |