Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-20.
At a glance
Inspections
9
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Nov 2025 – 20 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Sep 2022 – 9 Sep 2022 | Medical Devices & Rad Health | Clean | |
| 28 Mar 2018 – 29 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 17 Feb 2015 – 3 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Feb 2013 – 26 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 15 Oct 2010 | Not recorded | 483 | View 483 → |
| 11 Sep 2009 | Not recorded | 483 | View 483 → |
| 19 May 2006 | Not recorded | Clean | |
| 25 Feb 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Amy S Graf2 insp.
Deanna L Lampley2 insp.
Felicia E Armbrustmacher1 insp.
David J Gasparovich1 insp.
Sargum C Sood1 insp.
Ryan J Benedict1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Rockwell Medical, Inc's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat