Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-02-16.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2018 – 16 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 25 Jun 2014 – 14 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Mar 2013 – 6 May 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 9 Apr 2012 | Not recorded | WL | |
| 21 May 2008 | Not recorded | 483 | On file |
| 29 Aug 2007 | Not recorded | Clean | |
| 22 Jul 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jul 2014
21 CFR 820.20(b)
Lack of or inadequate organizational structure
Cited by Seema S Singh, Russell A Campbell
14 Jul 2014
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Seema S Singh, Russell A Campbell
14 Jul 2014
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Seema S Singh, Russell A Campbell
14 Jul 2014
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Seema S Singh, Russell A Campbell
Investigators
FDA investigators tied to this site in the record.
Seema S Singh2 insp.
Sara M Richardson1 insp.
Maida Henesian1 insp.
Russell A Campbell1 insp.
Joseph A Seitz1 insp.
Sergio Chavez1 insp.
Darla R Bracy1 insp.
Mohammad H Samimi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | 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(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | 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 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | 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 Medical Device Resource Corp's 3 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