Erika V. Butler
FDA investigator · also recorded as Enika V. Butler
Appears on 23 documents from 2007 to 2019, most often at sites in Colorado. Most often cites production record review (21 CFR 211.192).
- 23
- Documents on file
- 6.4
- Observations per 483
- 2007
- First seen
- 2019
- Most recent
What they cite most
From 129 observations- 21 CFR 211.192Production record review14
- 21 CFR 211.113Control of microbiological contamination13
- 21 CFR 211.165Testing and release for distribution9
- 21 CFR 211.22Responsibilities of quality control unit9
- 21 CFR 211.160General requirements8
- 21 CFR 211.42Design and construction features8
Activity by year
2007: 2, 2011: 2, 2012: 1, 2013: 2, 2014: 1, 2015: 4, 2016: 1, 2017: 2, 2018: 1, 2019: 7
Where
Colorado 7 · Utah 4 · California 2 · India 2 · Missouri 2 · Arizona 1
Often inspects with
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Inspection history
23 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-12-20 | 483 Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalDec 20, 2019 · Los Angeles, California | Los Angeles, California | 9 | |
| 2019-12-20 | 483 Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalDec 20, 2019 · Los Angeles, California | Los Angeles, California | 9 | |
| 2019-11-07 | 483 Upsher-Smith Laboratories, LLCNov 7, 2019 · Denver, Colorado | Denver, Colorado | 2 | |
| 2019-09-06 | 483 Glaxo Operations UK LtdSep 6, 2019 · Ware, United Kingdom | Ware, United Kingdom | 1 | |
| 2019-06-21 | 483 Fagron Compounding Service LLC dba Fagron Sterile ServicesJun 21, 2019 · Wichita, Kansas | Wichita, Kansas | 11 | |
| 2019-05-08 | 483 Velocity Production and PackagingMay 8, 2019 · Tempe, Arizona | Tempe, Arizona | 3 | |
| 2019-04-16 | 483 Sandoz IncApr 16, 2019 · Broomfield, Colorado | Broomfield, Colorado | 3 |
About this profile
What does Erika V. Butler inspect?
Erika V. Butler appears on 23 documents on file covering 17 sites, most often in Colorado.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.113 and 21 CFR 211.165.
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 Erika V. Butler is dated Dec 20, 2019.