Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-16.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Sep 2018 – 16 Oct 2018 | Medical Devices & Rad Health | Clean | |
| 17 Jan 2017 – 10 Feb 2017 | Medical Devices & Rad Health | WL | View 483 → |
| 25 Mar 2015 – 7 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Nov 2011 | Not recorded | 483 | On file |
| 9 Dec 2009 | Not recorded | 483 | View 483 → |
| 21 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2017
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by David J Gasparovich, Maksim A Levenchuk
10 Feb 2017
21 CFR 820.30(g)
Design validation - documentation
Cited by David J Gasparovich, Maksim A Levenchuk
10 Feb 2017
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by David J Gasparovich, Maksim A Levenchuk
10 Feb 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by David J Gasparovich, Maksim A Levenchuk
10 Feb 2017
21 CFR 820.160(a)
Lack of or inadequate procedures for distribution
Cited by David J Gasparovich, Maksim A Levenchuk
Investigators
FDA investigators tied to this site in the record.
Amanda Dinaro2 insp.
Naashon Deberry1 insp.
David J Gasparovich1 insp.
Maksim A Levenchuk1 insp.
Jesse A Vazquez1 insp.
James W Plucinski1 insp.
Paola S Barnett1 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 | 3x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Organ Recovery Systems, 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