FDA Inspection
Rockwell Medical Inc.Rockwell Medical Inc. – FDA Inspection, Mar 16, 2018
Record Details
This FDA Inspection record concerns Rockwell Medical Inc., with an inspection on March 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8a7276c1-0fd5-49f2-855b-b7e6130b484e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044459
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.70(f)Buildings
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
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Other FDA inspections of Rockwell Medical Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rockwell Medical Inc.
- FDA Inspection 1227165 - 2023-12-08
- FDA Inspection 897719 - 2014-09-12
- FDA Inspection 780578 - 2012-04-13
- FDA Inspection 597692 - 2009-03-13
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