James Michael Simpson
FDA investigator
Appears on 7 documents from 2015 to 2018, mostly at sites in Virginia. Most often cites design controls (21 CFR 820.30(c)).
- 7
- Documents on file
- 4.3
- Observations per 483
- 2015
- First seen
- 2018
- Most recent
What they cite most
From 30 observations- 21 CFR 820.30(c)Design controls4
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.188(b)(11)Batch production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.25(a)Personnel qualifications2
Activity by year
2015: 4, 2016: 1, 2017: 1, 2018: 1
Where
Virginia 4 · Maryland 3
Often inspects with
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Inspection history
7 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-08-16 | 483 PCCI, Inc.Aug 16, 2018 · Alexandria, Virginia | Alexandria, Virginia | 1 | |
| 2017-03-13 | 483 Trinity Sterile, Inc.Mar 13, 2017 · Salisbury, Maryland | Salisbury, Maryland | 2 | |
| 2016-04-19 | 483 Reflexonic, LLCApr 19, 2016 · Frederick, Maryland | Frederick, Maryland | 9 | |
| 2015-07-23 | 483 Tryco IncJul 23, 2015 · McLean, Virginia | McLean, Virginia | 1 | |
| 2015-05-22 | 483 Pharmaceutics International IncMay 22, 2015 · Hunt Valley, Maryland | Hunt Valley, Maryland | 3 | |
| 2015-04-23 | 483 Hawknad Manufacturing Industries, IncApr 23, 2015 · Alexandria, Virginia | Alexandria, Virginia | 12 | |
| 2015-03-12 | 483 C. B. Fleet CoMar 12, 2015 · Lynchburg, Virginia | Lynchburg, Virginia | 2 |
About this profile
What does James Michael Simpson inspect?
James Michael Simpson appears on 7 documents on file covering 7 sites, mostly in Virginia.
What do they cite most often?
21 CFR 820.30(c) (design controls), followed by 21 CFR 211.100 and 21 CFR 211.188(b)(11).
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 Michael Simpson is dated Aug 16, 2018.