Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-09-28.
At a glance
Inspections
2
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Aug 2015 – 28 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Sep 2014 – 3 Oct 2014 | Medical Devices & Rad Health | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Sep 2015
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Akbar J Zaidi, Samuel J Arsenault
28 Sep 2015
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Akbar J Zaidi, Samuel J Arsenault
28 Sep 2015
21 CFR 820.30(g)
Design validation acceptance criteria
Cited by Akbar J Zaidi, Samuel J Arsenault
28 Sep 2015
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Akbar J Zaidi, Samuel J Arsenault
28 Sep 2015
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Akbar J Zaidi, Samuel J Arsenault
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | 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 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Oxysure Systems, Inc.'s 2 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