FDA Inspection 1251365 — Rockwell Medical, Inc.
The FDA completed an inspection of Rockwell Medical, Inc. on Sep 16, 2024 in Grapevine, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 16, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Grapevine, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3696 | 21 CFR 820.100(b) | Documentation |