David H. Smith
FDA investigator
Appears on 1 document from 2018, mostly at sites in New Jersey. Most often cites if I am a manufacturer, what reporting requirements apply to me? (21 CFR 803.50(a)(1)).
- 1
- Documents on file
- 5.0
- Observations per 483
- 2018
- First seen
- 2018
- Most recent
What they cite most
From 5 observations- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.200(c)Servicing1
Activity by year
2018: 1
Where
New Jersey 1
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-09-27 | 483 Pentax of America IncSep 27, 2018 · Montvale, New Jersey | Montvale, New Jersey | 5 |
About this profile
What does David H. Smith inspect?
David H. Smith appears on 1 document on file covering 1 site, mostly in New Jersey.
What do they cite most often?
21 CFR 803.50(a)(1) (if I am a manufacturer, what reporting requirements apply to me?), followed by 21 CFR 803.17(a)(2) 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 David H. Smith is dated Sep 27, 2018.