James W. Whitney
FDA investigator
Appears on 3 documents from 2017 to 2018, most often at sites in Belgium. Most often cites design controls (21 CFR 820.30(g)).
- 3
- Documents on file
- 5.0
- Observations per 483
- 2017
- First seen
- 2018
- Most recent
What they cite most
From 15 observations- 21 CFR 820.30(g)Design controls4
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.22Responsibilities of quality control unit1
Activity by year
2017: 1, 2018: 2
Where
Belgium 1 · Massachusetts 1 · New Hampshire 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-10-26 | 483 Tender Corporation d/b/a Adventure Ready BrandsOct 26, 2018 · Littleton, New Hampshire | Littleton, New Hampshire | 2 | |
| 2018-07-31 | 483 Catalent Belgium SAJul 31, 2018 · Brussels, Belgium | Brussels, Belgium | 4 | |
| 2017-06-29 | 483 Magellan Diagnostics, Inc.Jun 29, 2017 · North Billerica, Massachusetts | North Billerica, Massachusetts | 9 |
About this profile
What does James W. Whitney inspect?
James W. Whitney appears on 3 documents on file covering 3 sites, most often in Belgium.
What do they cite most often?
21 CFR 820.30(g) (design controls), followed by 21 CFR 820.100(a) and 21 CFR 820.198(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 James W. Whitney is dated Oct 26, 2018.