Stryker Medical
Form 483 issued May 15, 2009 · Portage, Michigan
- Inspection
- May 11 – May 15, 2009
- Investigators
- Charles M. Spyr· Kimberl Lewandowski-Walker· Sullivan Myrick
- Observations
- 7
- Pages
- 4
- FEI number
- 1831750
In short: On May 15, 2009, FDA issued a Form 483 with 7 observations to Stryker Medical in Portage, Michigan (FEI 1831750) after an inspection that ran May 11 – May 15, 2009. The investigators were Charles M. Spyr, Kimberl Lewandowski-Walker, Sullivan Myrick and Urbiel Goldner. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Rework and reevaluation activities have not been fully documented in…
- 02
Procedures were not implemented for monitoring and control of process…
- 03
Procedures for changes to…
- 04
An J\!IT)R report was not submitted within 30 days of receiving or othervvise becoming aware of…
This inspection in context
Charles M. Spyr
3 documents · 2009–2015
Cites 820.100(a)(1) (corrective and preventive action) more than any other section. Most of their documents are for sites in Michigan.
The firmStryker Medical history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stryker Medical?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Stryker Medical?
Charles M. Spyr, Kimberl Lewandowski-Walker, Sullivan Myrick and Urbiel Goldner are named on this Form 483, for the inspection of May 11 – May 15, 2009. Each investigator has a profile showing what they cite most.
When was Stryker Medical inspected by FDA?
The inspection ran May 11 – May 15, 2009, and the Form 483 is dated May 15, 2009.
How do I get the full Form 483 for Stryker Medical?
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.