Xiaohui Shen
FDA investigator
Appears on 4 documents from 2017 to 2025, mostly at sites in California. Most often cites control of microbiological contamination (21 CFR 211.113).
- 4
- Documents on file
- 12.3
- Observations per 483
- 2017
- First seen
- 2025
- Most recent
What they cite most
From 49 observations- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42(c)(10)(iv)Design and construction features5
- 21 CFR 820.30Design controls5
- 21 CFR 211.22Responsibilities of quality control unit4
- FDCA 501(a)(2)(A)Insanitary conditions4
- 21 CFR 211.100Written procedures; deviations3
Activity by year
2017: 1, 2019: 1, 2023: 1, 2025: 1
Where
California 2 · North Carolina 1 · Tennessee 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-05-15 | 483 Apothecary Pharma LLCMay 15, 2025 · Cary, North Carolina | Cary, North Carolina | 8 | |
| 2023-08-25 | 483 Central Admixture Pharmacy Services IncAug 25, 2023 · San Diego, California | San Diego, California | 17 | |
| 2019-04-05 | 483 Anderson Compounding Pharmacy, Inc. dba Anderson Compounding PharmacyApr 5, 2019 · Bristol, Tennessee | Bristol, Tennessee | 4 | |
| 2017-03-31 | 483 Amphastar Pharmaceuticals, IncMar 31, 2017 · Rancho Cucamonga, California | Rancho Cucamonga, California | 20 |
About this profile
What does Xiaohui Shen inspect?
Xiaohui Shen appears on 4 documents on file covering 4 sites, mostly in California.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.42(c)(10)(iv) and 21 CFR 820.30.
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 Xiaohui Shen is dated May 15, 2025.