Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-13.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jan 2025 – 13 Jan 2025 | Medical Devices & Rad Health | Clean | |
| 18 Apr 2023 – 19 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 16 Mar 2020 – 18 Mar 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jun 2018 – 17 Jul 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Sep 2014 – 10 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Mar 2013 – 8 May 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 10 Sep 2012 | Not recorded | 483 | View 483 → |
| 3 Mar 2010 | Not recorded | Clean | |
| 9 Oct 2009 | Not recorded | 483 | View 483 → |
| 1 Jun 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Jesse A Vazquez, Emma R Schaefer
17 Jul 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Jesse A Vazquez, Emma R Schaefer
17 Jul 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Jesse A Vazquez, Emma R Schaefer
Investigators
FDA investigators tied to this site in the record.
Nicholas Z Lu2 insp.
Jesse A Vazquez2 insp.
Stephen D Eich2 insp.
Natasha R Johnson1 insp.
Shuana H Xiong1 insp.
Emma R Schaefer1 insp.
Audrey A De La Cruz1 insp.
Audrey De La Cruz1 insp.
Rafael Padilla1 insp.
Joseph A Morkunas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(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 803.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Richard Wolf Medical Instruments Corp.'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