FDA Inspection 823241 — Rockwell Medical, Inc.
The FDA completed an inspection of Rockwell Medical, Inc. on Mar 20, 2013 in Grapevine, TX. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 20, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Grapevine, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |