Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-01-21.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2011 | Not recorded | 483 | View 483 → |
| 17 Sep 2009 | Not recorded | 483 | View 483 → |
| 17 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jan 2011
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Bleta Vuniqi, Tracey L Siebesma, Ryan J Benedict
21 Jan 2011
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Bleta Vuniqi, Tracey L Siebesma, Ryan J Benedict
17 Sep 2009
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Tracey L Siebesma
Investigators
FDA investigators tied to this site in the record.
Tracey L Siebesma3 insp.
Bleta Vuniqi1 insp.
Ryan J Benedict1 insp.
Aaron B Otis1 insp.
Anastasia M Piliafas-Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DavisMade, Inc.'s 3 Form 483s
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