Stryker Craniomaxillofacial Division
Form 483 issued December 10, 2008 · Portage, Michigan
- Inspection
- Dec 8 – Dec 10, 2008
- Investigators
- Eric S. Pittman· Gary D. Urbiel Goldner· William D. Tingley
- Observations
- 1
- Pages
- 3
- FEI number
- 3005101424
In short: On December 10, 2008, FDA issued a Form 483 with 1 observation to Stryker Craniomaxillofacial Division in Portage, Michigan (FEI 3005101424) after an inspection that ran Dec 8 – Dec 10, 2008. The investigators were Eric S. Pittman, Gary D. Urbiel Goldner and William D. Tingley. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint handling procedures have not been implemented to ensure that all complaints are processed in a…
This inspection in context
Eric S. Pittman
2 documents · 2008–2009
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Indiana.
The firmStryker Craniomaxillofacial Division history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stryker Craniomaxillofacial Division?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Stryker Craniomaxillofacial Division?
Eric S. Pittman, Gary D. Urbiel Goldner and William D. Tingley are named on this Form 483, for the inspection of Dec 8 – Dec 10, 2008. Each investigator has a profile showing what they cite most.
When was Stryker Craniomaxillofacial Division inspected by FDA?
The inspection ran Dec 8 – Dec 10, 2008, and the Form 483 is dated December 10, 2008.
How do I get the full Form 483 for Stryker Craniomaxillofacial Division?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.