Yumi J. Hiramine
FDA investigator
Appears on 3 documents from 2015 to 2019, most often at sites in Canada. Most often cites equipment cleaning and maintenance (21 CFR 211.67(b)).
- 3
- Documents on file
- 6.3
- Observations per 483
- 2015
- First seen
- 2019
- Most recent
What they cite most
From 19 observations- 21 CFR 211.67(b)Equipment cleaning and maintenance3
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
Activity by year
2015: 1, 2019: 2
Where
Canada 1 · Germany 1 · Texas 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-11-22 | 483 Merz Pharma GmbH & Co KGaANov 22, 2019 · Dessau-Rosslau, Germany | Dessau-Rosslau, Germany | 4 | |
| 2019-06-07 | 483 PLZ CorpJun 7, 2019 · Mississauga, Canada | Mississauga, Canada | 4 | |
| 2015-07-01 | 483 Pharma Nobis, LLCJul 1, 2015 · Texarkana, Texas | Texarkana, Texas | 11 |
About this profile
What does Yumi J. Hiramine inspect?
Yumi J. Hiramine appears on 3 documents on file covering 3 sites, most often in Canada.
What do they cite most often?
21 CFR 211.67(b) (equipment cleaning and maintenance), followed by 21 CFR 211.68(a) 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 Yumi J. Hiramine is dated Nov 22, 2019.