Stephen R. Souza
FDA investigator
Appears on 4 documents from 2016 to 2019, mostly at sites in Washington. Most often cites what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? (21 CFR 803.17).
- 4
- Documents on file
- 3.5
- Observations per 483
- 2016
- First seen
- 2019
- Most recent
What they cite most
From 13 observations- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 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 820.100(a)Corrective and preventive action2
- 21 CFR 803.30(a)(2)If I am a user facility, what reporting requirements apply to me?1
- 21 CFR 803.52(b)(2)If I am a manufacturer, what information must I submit in my individual adverse event reports?1
- 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?1
Activity by year
2016: 1, 2017: 1, 2018: 1, 2019: 1
Where
Washington 4
Often inspects with
Christopher S. Genther· Paul M. Kawamoto· Sharon I. Gundersen
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-11-26 | 483 Physio-Control, IncNov 26, 2019 · Redmond, Washington | Redmond, Washington | 5 | |
| 2018-03-14 | 483 The Feminina Group, Inc.Mar 14, 2018 · Seattle, Washington | Seattle, Washington | 3 | |
| 2017-12-15 | 483 Physio-Control, IncDec 15, 2017 · Redmond, Washington | Redmond, Washington | 2 | |
| 2016-04-15 | 483 Virginia Mason Medical CenterApr 15, 2016 · Seattle, Washington | Seattle, Washington | 4 |
About this profile
What does Stephen R. Souza inspect?
Stephen R. Souza appears on 4 documents on file covering 3 sites, mostly in Washington.
What do they cite most often?
21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), followed by 21 CFR 803.18(b)(1)(i) and 21 CFR 820.100(a).
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 Stephen R. Souza is dated Nov 26, 2019.