Tomika L. Bivens
FDA investigator
Appears on 3 documents from 2014 to 2020, most often at sites in Colorado. Most often cites written procedures; deviations (21 CFR 211.100).
- 3
- Documents on file
- 6.0
- Observations per 483
- 2014
- First seen
- 2020
- Most recent
What they cite most
From 18 observations- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.122(a)Materials examination and usage criteria1
Activity by year
2014: 1, 2015: 1, 2020: 1
Where
Colorado 1 · India 1 · North Carolina 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-02-28 | 483 Matrix Pharmacorp Private LimitedFeb 28, 2020 · Patancheru, India | Patancheru, India | 5 | |
| 2015-04-27 | 483 Brown’s Compounding Center, Inc.Apr 27, 2015 · Englewood, Colorado | Englewood, Colorado | 6 | |
| 2014-09-22 | 483 Triangle CompoundingSep 22, 2014 · Cary, North Carolina | Cary, North Carolina | 7 |
About this profile
What does Tomika L. Bivens inspect?
Tomika L. Bivens appears on 3 documents on file covering 3 sites, most often in Colorado.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.84 and 21 CFR 211.113(b).
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 Tomika L. Bivens is dated Feb 28, 2020.