Sharon K. Thoma
FDA investigator
Appears on 9 documents from 2009 to 2016, most often at sites in Pennsylvania. Most often cites general requirements (21 CFR 211.160).
- 9
- Documents on file
- 12.9
- Observations per 483
- 2009
- First seen
- 2016
- Most recent
What they cite most
From 91 observations- 21 CFR 211.160General requirements12
- 21 CFR 211.192Production record review9
- 21 CFR 211.100Written procedures; deviations8
- 21 CFR 211.165Testing and release for distribution5
- 21 CFR 211.198Complaint files5
- 21 CFR 211.22Responsibilities of quality control unit5
Activity by year
2009: 1, 2010: 2, 2011: 1, 2012: 1, 2014: 1, 2015: 2, 2016: 1
Where
Pennsylvania 3 · Canada 1 · Germany 1 · India 1 · Massachusetts 1 · Texas 1
Often inspects with
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Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2016-04-26 | 483 Vetter Pharma Fertigung GmbH & Co. KGApr 26, 2016 · Langenargen, Germany | Langenargen, Germany | 6 | |
| 2015-07-17 | 483 Mutual Pharmaceutical CompanyJul 17, 2015 · Philadelphia, Pennsylvania | Philadelphia, Pennsylvania | 10 | |
| 2015-04-06 | 483 Valens Molecules Private LimitedApr 6, 2015 · Hyderabad, India | Hyderabad, India | 12 | |
| 2014-10-08 | 483 New England Home Therapies, Inc.Oct 8, 2014 · Southborough, Massachusetts | Southborough, Massachusetts | 7 | |
| 2012-08-24 | 483 Hospira, Inc.Aug 24, 2012 · Austin, Texas | Austin, Texas | 19 | |
| 2011-08-04 | 483 Sandoz Canada, IncAug 4, 2011 · Boucherville, Canada | Boucherville, Canada | 1 | |
| 2010-07-09 | 483 Johnson and Johnson (McNeil)Jul 9, 2010 · Lancaster, Pennsylvania | Lancaster, Pennsylvania | 12 |
About this profile
What does Sharon K. Thoma inspect?
Sharon K. Thoma appears on 9 documents on file covering 9 sites, most often in Pennsylvania.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.192 and 21 CFR 211.100.
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 Sharon K. Thoma is dated Apr 26, 2016.