Stryker Instruments
FDA inspection history in Kalamazoo, Michigan, 2009
- 1
- Form 483
Every document, by year
- Form 483
2009: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One Form 483, at Kalamazoo, Michigan.
Cited most
Across all Stryker Instruments observations on file
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.250(b)Statistical techniques1
The complete Stryker Instruments file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Kalamazoo, Michigan
One Form 483 · 2009 · 8 observations
Latest: Form 483, May 14, 2009 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2009-05-14 | 483 Form 483 | Kalamazoo, Michigan | 8 | $99 |
Investigators on these documents
Charles M. Spyr (1)Gary D. Urbiel Goldner (1)Kimberl Lewandowski-Walker (1)Martha Sullivan Myrick (1)
FEI number 1811755 · most recent document May 14, 2009
About Stryker Instruments
How many FDA Form 483s has Stryker Instruments received?
FDA Intel has 1 Form 483 on file for Stryker Instruments; the most recent is dated May 14, 2009.
When was Stryker Instruments last inspected by FDA?
The most recent FDA inspection document on file for Stryker Instruments is a Form 483 dated May 14, 2009, for the site in Kalamazoo, Michigan.
What did FDA cite at Stryker Instruments?
The regulations cited most in the observations on file for Stryker Instruments are 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820.90(a) (Nonconforming product), 2 times; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.