Stryker Instruments
Form 483 issued May 14, 2009 · Kalamazoo, Michigan
- Inspection
- May 4 – May 14, 2009
- Investigators
- Charles M. Spyr· Gary D. Urbiel Goldner· Kimberl Lewandowski-Walker
- Observations
- 8
- Pages
- 10
- FEI number
- 1811755
In short: On May 14, 2009, FDA issued a Form 483 with 8 observations to Stryker Instruments in Kalamazoo, Michigan (FEI 1811755) after an inspection that ran May 4 – May 14, 2009. The investigators were Charles M. Spyr, Gary D. Urbiel Goldner, Kimberl Lewandowski-Walker and Martha Sullivan Myrick. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 8 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Potential suppliers and contractors were not sufficiently evaluated and selected on the basis of their ability…
- 04
Procedures for addressing the identification, evaluation, and investigation of nonconforming…
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 Instruments history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stryker Instruments?
FDA listed 8 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Stryker Instruments?
Charles M. Spyr, Gary D. Urbiel Goldner, Kimberl Lewandowski-Walker and Martha Sullivan Myrick are named on this Form 483, for the inspection of May 4 – May 14, 2009. Each investigator has a profile showing what they cite most.
When was Stryker Instruments inspected by FDA?
The inspection ran May 4 – May 14, 2009, and the Form 483 is dated May 14, 2009.
How do I get the full Form 483 for Stryker Instruments?
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.