Stephen C. Smith
FDA investigator
Appears on 4 documents from 2015 to 2021, mostly at sites in New Hampshire. Most often cites if I am a user facility, what reporting requirements apply to me? (21 CFR 803.30).
- 4
- Documents on file
- 3.0
- Observations per 483
- 2015
- First seen
- 2021
- Most recent
What they cite most
From 12 observations- 21 CFR 803.30If I am a user facility, what reporting requirements apply to me?3
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?2
- 21 CFR 820.70(c)Production and process controls2
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.120(d)Device labeling1
Activity by year
2015: 2, 2020: 1, 2021: 1
Where
New Hampshire 2 · Connecticut 1 · Massachusetts 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-07-15 | 483 CooperSurgical, Inc.Jul 15, 2021 · Trumbull, Connecticut | Trumbull, Connecticut | 4 | |
| 2020-08-26 | 483 Benchmark Electronics, IncAug 26, 2020 · Nashua, New Hampshire | Nashua, New Hampshire | 1 | |
| 2015-12-17 | 483 Dartmouth-Hitchcock Medical CenterDec 17, 2015 · Lebanon, New Hampshire | Lebanon, New Hampshire | 3 | |
| 2015-12-10 | 483 Brigham and Women’s HospitalDec 10, 2015 · Boston, Massachusetts | Boston, Massachusetts | 4 |
About this profile
What does Stephen C. Smith inspect?
Stephen C. Smith appears on 4 documents on file covering 4 sites, mostly in New Hampshire.
What do they cite most often?
21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?), followed by 21 CFR 803.17 and 21 CFR 803.18.
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 C. Smith is dated Jul 15, 2021.