Bei Y. He
FDA investigator
Appears on 14 documents from 2016 to 2025, most often at sites in Michigan. Most often cites control of microbiological contamination (21 CFR 211.113).
- 14
- Documents on file
- 6.4
- Observations per 483
- 2016
- First seen
- 2025
- Most recent
What they cite most
From 99 observations- 21 CFR 211.113Control of microbiological contamination17
- 21 CFR 211.42Design and construction features13
- 21 CFR 211.22Responsibilities of quality control unit9
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.192Production record review6
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures5
Activity by year
2016: 2, 2017: 2, 2018: 2, 2019: 4, 2020: 1, 2021: 1, 2025: 2
Where
Michigan 5 · Canada 2 · Indiana 2 · Alabama 1 · Florida 1 · Illinois 1
Often inspects with
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Inspection history
14 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-12-19 | 483 F.H. Investments, Inc. (dba Asteria Health)Dec 19, 2025 · Birmingham, Alabama | Birmingham, Alabama | 10 | |
| 2025-07-18 | 483 GenoGeni xJul 18, 2025 · Boca Raton, Florida | Boca Raton, Florida | 16 | |
| 2021-07-02 | 483 Grand River Aseptic Manufacturing, Inc.Jul 2, 2021 · Grand Rapids, Michigan | Grand Rapids, Michigan | 8 | |
| 2020-10-29 | 483 Advanced Nutriceuticals, LLCOct 29, 2020 · Indianapolis, Indiana | Indianapolis, Indiana | 4 | |
| 2019-07-31 | 483 Nesher Pharmaceuticals (USA) LLCJul 31, 2019 · Bridgeton, Missouri | Bridgeton, Missouri | 3 | |
| 2019-06-18 | 483 Novocol Pharmaceutical of Canada, Inc.Jun 18, 2019 · Cambridge, Canada | Cambridge, Canada | 1 | |
| 2019-06-06 | 483 Innocore Sales & Marketing IncJun 6, 2019 · Woodstock, Canada | Woodstock, Canada | 12 |
About this profile
What does Bei Y. He inspect?
Bei Y. He appears on 14 documents on file covering 14 sites, most often in Michigan.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.42 and 21 CFR 211.22.
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 Bei Y. He is dated Dec 19, 2025.