Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-02.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Aug 2021 – 2 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 8 Nov 2018 – 20 Nov 2018 | Medical Devices & Rad Health | Clean | |
| 15 May 2018 – 18 May 2018 | Medical Devices & Rad Health | 483 | On file |
| 8 Mar 2017 – 31 Mar 2017 | Medical Devices & Rad Health | 483 | On file |
| 17 Sep 2015 – 14 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2014 – 16 Dec 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 18 Nov 2011 | Not recorded | Clean | |
| 11 Feb 2009 | Not recorded | Clean | |
| 21 Aug 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Oct 2015
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Kirtida Patel, Angela Shepas
14 Oct 2015
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Kirtida Patel, Angela Shepas
Investigators
FDA investigators tied to this site in the record.
Kirtida Patel3 insp.
Cntrctmntr Anderson2 insp.
Kelvin Cheung1 insp.
MDSAP harperd1 insp.
Juanita Banuelos1 insp.
Angela Shepas1 insp.
James R Fleckenstein1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | 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(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Applied Medical Resources Corp's 5 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