Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-01-24.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jan 2018 – 24 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 May 2013 – 9 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 May 2006 | Not recorded | Clean | |
| 2 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jan 2018
21 CFR 820.184
DHR - not or inadequately maintained
Cited by Melissa A Freeman, Melissa A Zuppe
24 Jan 2018
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Melissa A Freeman, Melissa A Zuppe
9 May 2013
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Charles Chacko
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 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vitaire Corp.'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