FDA Inspection
Rockwell Medical, Inc.Rockwell Medical, Inc. – FDA Inspection, Sep 16, 2024
Record Details
This FDA Inspection record concerns Rockwell Medical, Inc., with an inspection on September 16, 2024, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- Rockwell Medical, Inc.
- Inspection Date
- September 16, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ad70f012-096d-4b4b-b9dd-a04960cf29ed
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1251365
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(e)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rockwell Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 13, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 8, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rockwell Medical, Inc.
- FDA Inspection 1175266 - 2022-07-25
- FDA Inspection 959876 - 2016-01-13
- FDA Inspection 823241 - 2013-03-20
- FDA Inspection 701961 - 2010-12-08
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