Kimberly Lewandowski-Walker
FDA investigator
Appears on 5 documents from 2005 to 2017, most often at sites in Florida. Most often cites corrective and preventive action (21 CFR 820.100).
- 5
- Documents on file
- 8.8
- Observations per 483
- 2005
- First seen
- 2017
- Most recent
What they cite most
From 27 observations- 21 CFR 820.100Corrective and preventive action7
- 21 CFR 820.75Process validation3
- 21 CFR 820.184Device history record2
- 21 CFR 820.198Complaint files2
- 21 CFR 820.20Management responsibility2
- 21 CFR 820.30Design controls2
Activity by year
2005: 1, 2010: 1, 2015: 2, 2017: 1
Where
Florida 1 · Indiana 1 · Minnesota 1 · Puerto Rico 1 · Texas 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-03-23 | 483 Oscor, IncMar 23, 2017 · Palm Harbor, Florida | Palm Harbor, Florida | 7 | |
| 2015-11-17 | 483 Zimmer Manufacturing B.VNov 17, 2015 · Mercedita, Puerto Rico | Mercedita, Puerto Rico | 4 | |
| 2015-07-11 | Amended 483 Terumo Cardiovascular Systems CorporationJul 11, 2015 · Ann Arbor, Indiana | Ann Arbor, Indiana | 15 | |
| 2010-09-15 | Response Advanced Neuromodulation Systems, Inc.Sep 15, 2010 · Plano, Texas | Plano, Texas | — | |
| 2005-09-01 | 483 Guidant CorporationSep 1, 2005 · Saint Paul, Minnesota | Saint Paul, Minnesota | 9 |
About this profile
What does Kimberly Lewandowski-Walker inspect?
Kimberly Lewandowski-Walker appears on 5 documents on file covering 4 sites, most often in Florida.
What do they cite most often?
21 CFR 820.100 (corrective and preventive action), followed by 21 CFR 820.75 and 21 CFR 820.184.
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 Kimberly Lewandowski-Walker is dated Mar 23, 2017.