Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-15.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jun 2023 – 15 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jun 2016 – 17 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 May 2013 – 30 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Aug 2012 | Not recorded | WL | View 483 → |
| 20 Apr 2012 | Not recorded | 483 | View 483 → |
| 21 Jun 2010 | Not recorded | 483 | View 483 → |
| 2 Sep 2003 | Not recorded | Clean | |
| 11 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jun 2023
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Stephen R Souza
15 Jun 2023
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Stephen R Souza
15 Jun 2023
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Stephen R Souza
Investigators
FDA investigators tied to this site in the record.
Stanley B Eugene3 insp.
Ashleigh P Barkans2 insp.
Graham N Giesen2 insp.
Stephen R Souza1 insp.
Celia L Silverstein1 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 | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 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 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Parks Medical Electronics, Inc's 6 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