Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-29.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Oct 2022 – 29 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jun 2022 | Foods & Cosmetics | Clean | |
| 20 Aug 2019 – 21 Aug 2019 | Foods & Cosmetics | WL | |
| 20 Aug 2018 – 22 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Oct 2014 | Medical Devices & Rad Health | Clean | |
| 8 Jul 2011 | Not recorded | Clean | |
| 11 Jan 2011 | Not recorded | WL | View 483 → |
| 17 Aug 2009 | Not recorded | 483 | View 483 → |
| 28 Oct 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Nov 2022
21 CFR 820.20(b)
Lack of or inadequate organizational structure
Cited by Dennis R Hock, Nadia R Barreda
29 Nov 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Dennis R Hock, Nadia R Barreda
Investigators
FDA investigators tied to this site in the record.
Cynthia A Harris5 insp.
Dennis R Hock1 insp.
Nadia R Barreda1 insp.
William A Warnick1 insp.
Jamie D Swann1 insp.
Tiki Dixon1 insp.
Nebil A Oumer1 insp.
Jesse P Hardin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Rebuilder 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