Michael Y. Philopoulos
FDA investigator
Appears on 4 documents from 2014 to 2019, mostly at sites in Indiana. Most often cites design and construction features (21 CFR 211.42).
- 4
- Documents on file
- 5.5
- Observations per 483
- 2014
- First seen
- 2019
- Most recent
What they cite most
From 22 observations- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.166Stability testing2
- 21 CFR 211.192Production record review2
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.67Equipment cleaning and maintenance2
Activity by year
2014: 1, 2018: 1, 2019: 2
Where
Indiana 2 · Japan 1 · Wisconsin 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-09-10 | 483 Otsuka Pharmaceutical Co LtdSep 10, 2019 · Tokushima, Japan | Tokushima, Japan | 1 | |
| 2019-07-17 | 483 D&D Pharma, LLC dba MedScript Compounding PharmacyJul 17, 2019 · Noblesville, Indiana | Noblesville, Indiana | 3 | |
| 2018-08-07 | 483 The Pet Apothecary LLCAug 7, 2018 · Milwaukee, Wisconsin | Milwaukee, Wisconsin | 9 | |
| 2014-12-16 | 483 Coram Healthcare Corp. of IndianaDec 16, 2014 · Crown Point, Indiana | Crown Point, Indiana | 9 |
About this profile
What does Michael Y. Philopoulos inspect?
Michael Y. Philopoulos appears on 4 documents on file covering 4 sites, mostly in Indiana.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.166.
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 Michael Y. Philopoulos is dated Sep 10, 2019.