Edward M. James
FDA investigator
Appears on 1 document from 2015, mostly at sites in Minnesota. Most often cites what requirements apply to the review and investigation of a product complaint? (21 CFR 111.560(a)(1)).
- 1
- Documents on file
- 4.0
- Observations per 483
- 2015
- First seen
- 2015
- Most recent
What they cite most
From 4 observations- 21 CFR 111.560(a)(1)What requirements apply to the review and investigation of a product complaint?1
- 21 CFR 111.70(e)What specifications must you establish?1
- 21 CFR 111.77(a)What must you do if established specifications are not met?1
- FDCA 761(b)(1)1
Activity by year
2015: 1
Where
Minnesota 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2015-04-10 | 483 Nutri-Dyn Midwest, IncApr 10, 2015 · Maple Plain, Minnesota | Maple Plain, Minnesota | 4 |
About this profile
What does Edward M. James inspect?
Edward M. James appears on 1 document on file covering 1 site, mostly in Minnesota.
What do they cite most often?
21 CFR 111.560(a)(1) (what requirements apply to the review and investigation of a product complaint?), followed by 21 CFR 111.70(e) and 21 CFR 111.77(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 Edward M. James is dated Apr 10, 2015.