Kimberl Lewandowski-Walker
FDA investigator
Appears on 2 documents from 2009, mostly at sites in Michigan. Most often cites process validation (21 CFR 820.75(a)).
- 2
- Documents on file
- 7.5
- Observations per 483
- 2009
- First seen
- 2009
- Most recent
What they cite most
From 15 observations- 21 CFR 820.75(a)Process validation3
- 21 CFR 820.90(a)Nonconforming product3
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.250(b)Statistical techniques1
Activity by year
2009: 2
Where
Michigan 2
Often inspects with
Charles M. Spyr· Gary D. Urbiel Goldner· Martha Sullivan Myrick
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2009-05-15 | 483 Stryker MedicalMay 15, 2009 · Portage, Michigan | Portage, Michigan | 7 | |
| 2009-05-14 | 483 Stryker InstrumentsMay 14, 2009 · Kalamazoo, Michigan | Kalamazoo, Michigan | 8 |
About this profile
What does Kimberl Lewandowski-Walker inspect?
Kimberl Lewandowski-Walker appears on 2 documents on file covering 2 sites, mostly in Michigan.
What do they cite most often?
21 CFR 820.75(a) (process validation), followed by 21 CFR 820.90(a) and 21 CFR 803.50(a)(2).
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Kimberl Lewandowski-Walker is dated May 15, 2009.