Ruo H. Xu
FDA investigator
Appears on 4 documents from 2017 to 2024, most often at sites in Florida. Most often cites design and construction features (21 CFR 211.42).
- 4
- Documents on file
- 8.0
- Observations per 483
- 2017
- First seen
- 2024
- Most recent
What they cite most
From 32 observations- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
Activity by year
2017: 1, 2024: 3
Where
Florida 1 · Indiana 1 · Italy 1 · Japan 1
Often inspects with
Ileana Barreto-Pettit· Jennifer L. Huntington· Laurimer Kuilan-Torres
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-12-13 | 483 TERUMO CORPORATIONDec 13, 2024 · SHOWACHO, Japan | SHOWACHO, Japan | 6 | |
| 2024-06-19 | 483 NerPharMa S.r.lJun 19, 2024 · Nerviano, Italy | Nerviano, Italy | 8 | |
| 2024-02-20 | 483 Simtra US LLCFeb 20, 2024 · Bloomington, Indiana | Bloomington, Indiana | 7 | |
| 2017-05-26 | 483 Bausch & Lomb IncorporatedMay 26, 2017 · Tampa, Florida | Tampa, Florida | 11 |
About this profile
What does Ruo H. Xu inspect?
Ruo H. Xu appears on 4 documents on file covering 4 sites, most often in Florida.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.160.
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 Ruo H. Xu is dated Dec 13, 2024.