Stryker Medical
FDA inspection history in Portage, 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 Portage, Michigan.
Cited most
Across all Stryker Medical observations on file
- 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 820.25(b)Personnel1
- 21 CFR 820.30(i)Design controls1
- 21 CFR 820.70(b)Production and process controls1
The complete Stryker Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Portage, Michigan
One Form 483 · 2009 · 7 observations
Latest: Form 483, May 15, 2009 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2009-05-15 | 483 Form 483 | Portage, Michigan | 7 | $99 |
Investigators on these documents
Charles M. Spyr (1)Kimberl Lewandowski-Walker (1)Sullivan Myrick (1)Urbiel Goldner (1)
FEI number 1831750 · most recent document May 15, 2009
About Stryker Medical
How many FDA Form 483s has Stryker Medical received?
FDA Intel has 1 Form 483 on file for Stryker Medical; the most recent is dated May 15, 2009.
When was Stryker Medical last inspected by FDA?
The most recent FDA inspection document on file for Stryker Medical is a Form 483 dated May 15, 2009, for the site in Portage, Michigan.
What did FDA cite at Stryker Medical?
The regulations cited most in the observations on file for Stryker Medical are 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.25(b) (Personnel), 1 time.