FDA Inspection
Rockwell Medical, IncRockwell Medical, Inc – FDA Inspection, Nov 20, 2025
Record Details
This FDA Inspection record concerns Rockwell Medical, Inc, with an inspection on November 20, 2025, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Rockwell Medical, Inc
- Inspection Date
- November 20, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ff50c6ce-f855-425e-a55b-7c3e65ff8dd4
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1292132
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.72(b)Remedial action
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rockwell Medical, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 29, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 3, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rockwell Medical, Inc
- FDA Inspection 1179947 - 2022-09-09
- FDA Inspection 1048235 - 2018-03-29
- FDA Inspection 914050 - 2015-04-03
- FDA Inspection 817995 - 2013-02-26
- FDA Inspection 695818 - 2010-10-15
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