Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-05-16.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2019 – 16 May 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Sep 2014 – 30 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 15 Dec 2010 | Not recorded | Clean | |
| 2 Feb 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Jennifer S Ness, Marissa S Steinhagen, Tiffany P Kelley
16 May 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Jennifer S Ness, Marissa S Steinhagen, Tiffany P Kelley
16 May 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Jennifer S Ness, Marissa S Steinhagen, Tiffany P Kelley
16 May 2019
21 CFR 820.184
DHR content
Cited by Jennifer S Ness, Marissa S Steinhagen, Tiffany P Kelley
16 May 2019
21 CFR 820.184
DHR content
Cited by Jennifer S Ness, Marissa S Steinhagen, Tiffany P Kelley
Investigators
FDA investigators tied to this site in the record.
Jennifer S Ness1 insp.
Marissa S Steinhagen1 insp.
Tiffany P Kelley1 insp.
Yehualashe A Gessesse1 insp.
Alan R Albrecht1 insp.
James A Beaulieu1 insp.
Mada A Tautges1 insp.
Paola E Lathrop1 insp.
Kellie L Westerbuhr1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Vasamed, Inc.'s 1 Form 483
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