Sharon I. Gundersen
FDA investigator
Appears on 3 documents from 2015 to 2016, mostly at sites in Washington. Most often cites design controls (21 CFR 820.30(c)).
- 3
- Documents on file
- 6.3
- Observations per 483
- 2015
- First seen
- 2016
- Most recent
What they cite most
From 9 observations- 21 CFR 820.30(c)Design controls4
- 21 CFR 803.18(b)(1)(i)What are the requirements for establishing and maintaining MDR files or records that apply to me?2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.30(a)(2)If I am a user facility, what reporting requirements apply to me?1
- 21 CFR 820.184Device history record1
Activity by year
2015: 1, 2016: 2
Where
Washington 3
Often inspects with
Christopher S. Genther· Stephen R. Souza· Cynthia L. Gorveatt
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2016-07-27 | 483 Natus Medical IncorporatedJul 27, 2016 · Seattle, Washington | Seattle, Washington | 12 | |
| 2016-04-15 | 483 Virginia Mason Medical CenterApr 15, 2016 · Seattle, Washington | Seattle, Washington | 4 | |
| 2015-10-29 | 483 Evergreen Orthopedic Research Lab, LLCOct 29, 2015 · Kirkland, Washington | Kirkland, Washington | 3 |
About this profile
What does Sharon I. Gundersen inspect?
Sharon I. Gundersen appears on 3 documents on file covering 3 sites, mostly in Washington.
What do they cite most often?
21 CFR 820.30(c) (design controls), followed by 21 CFR 803.18(b)(1)(i) and 21 CFR 803.17.
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 Sharon I. Gundersen is dated Jul 27, 2016.