James M. Mason
FDA investigator
Appears on 13 documents from 2011 to 2020, mostly at sites in Pennsylvania. Most often cites control of microbiological contamination (21 CFR 211.113).
- 13
- Documents on file
- 6.6
- Observations per 483
- 2011
- First seen
- 2020
- Most recent
What they cite most
From 79 observations- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.160General requirements7
- 21 CFR 211.192Production record review7
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.165Testing and release for distribution4
Activity by year
2011: 2, 2015: 3, 2016: 1, 2017: 4, 2018: 1, 2020: 2
Where
Pennsylvania 11 · Maryland 1 · West Virginia 1
Often inspects with
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Inspection history
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-02-09 | 483 Walter’s PharmacyFeb 9, 2020 · Allentown, Pennsylvania | Allentown, Pennsylvania | 5 | |
| 2020-02-09 | 483 Dorneyville PharmacyFeb 9, 2020 · Allentown, Pennsylvania | Allentown, Pennsylvania | 14 | |
| 2018-04-12 | 483 Mylan Pharmaceuticals Inc.Apr 12, 2018 · Morgantown, West Virginia | Morgantown, West Virginia | 13 | |
| 2017-11-16 | 483 Pharmaceutics International, Inc.Nov 16, 2017 · Hunt Valley, Maryland | Hunt Valley, Maryland | 10 | |
| 2017-08-29 | 483 US Specialty Formulations LLCAug 29, 2017 · Bethlehem, Pennsylvania | Bethlehem, Pennsylvania | 7 | |
| 2017-07-20 | 483 Hayward Laboratories, IncJul 20, 2017 · E Stroudsburg, Pennsylvania | E Stroudsburg, Pennsylvania | 9 | |
| 2017-05-25 | 483 Pharmaceutical Manufacturing Research Services, Inc.May 25, 2017 · Horsham, Pennsylvania | Horsham, Pennsylvania | 1 |
About this profile
What does James M. Mason inspect?
James M. Mason appears on 13 documents on file covering 11 sites, mostly in Pennsylvania.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.160 and 21 CFR 211.192.
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 M. Mason is dated Feb 9, 2020.