Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2010-08-02.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Aug 2010 | Not recorded | 483 | View 483 → |
| 10 Dec 2008 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Aug 2010
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Eric S Pittman, Anthony R Petriella
10 Dec 2008
21 CFR 820.198(a)(1)
Uniform and timely processing
Cited by Eric S Pittman, William D Tingley, Gary D Urbiel Goldner
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 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Stryker Craniomaxillofacial Division'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