Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-12-01.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Nov 2016 – 1 Dec 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2014 – 21 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jun 2011 | Not recorded | 483 | View 483 → |
| 14 Oct 2004 | Not recorded | Clean | |
| 26 Nov 2003 | Not recorded | Clean | |
| 8 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Dec 2016
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Raffi B Papazian
21 Feb 2014
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Raffi B Papazian
8 Jun 2011
21 CFR 820.20(a)
Management ensuring quality policy is understood
Cited by Raffi B Papazian, Michael J Nerz
Investigators
FDA investigators tied to this site in the record.
Raffi B Papazian3 insp.
Michael J Nerz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Premier Dental Products Company's 3 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