Thomas R. Withers
FDA investigator
Appears on 5 documents from 2022 to 2023, most often at sites in Virginia. Most often cites written procedures; deviations (21 CFR 211.100).
- 5
- Documents on file
- 3.4
- Observations per 483
- 2022
- First seen
- 2023
- Most recent
What they cite most
From 17 observations- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 117.135(c)(3)Preventive controls1
- 21 CFR 117.410(c)General requirements applicable to a supply-chain program1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
Activity by year
2022: 4, 2023: 1
Where
Virginia 2 · California 1 · North Carolina 1 · Pennsylvania 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-10-06 | 483 Afton Scientific, LLCOct 6, 2023 · Charlottesville, Virginia | Charlottesville, Virginia | 8 | |
| 2022-12-09 | 483 BioMarin Pharmaceutical Inc.Dec 9, 2022 · Novato, California | Novato, California | 2 | |
| 2022-11-04 | 483 Barr Laboratories LLCNov 4, 2022 · Forest, Virginia | Forest, Virginia | 1 | |
| 2022-10-21 | 483 Packaging Coordinators, LLCOct 21, 2022 · Philadelphia, Pennsylvania | Philadelphia, Pennsylvania | 2 | |
| 2022-08-04 | 483 Patheon Manufacturing Services LLCAug 4, 2022 · Greenville, North Carolina | Greenville, North Carolina | 4 |
About this profile
What does Thomas R. Withers inspect?
Thomas R. Withers appears on 5 documents on file covering 5 sites, most often in Virginia.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.192 and 21 CFR 211.22(d).
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 Thomas R. Withers is dated Oct 6, 2023.