FDA Inspection 1292132 — Rockwell Medical, Inc
The FDA completed an inspection of Rockwell Medical, Inc on November 20, 2025 in Wixom, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 20, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wixom, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |