Zhongren Wu
FDA investigator · also recorded as Th Zhongren Wu
Appears on 8 documents from 2015 to 2021, most often at sites in Maryland. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 8
- Documents on file
- 4.7
- Observations per 483
- 2015
- First seen
- 2021
- Most recent
What they cite most
From 29 observations- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
Activity by year
2015: 1, 2016: 3, 2018: 2, 2019: 1, 2021: 1
Where
Maryland 2 · Belgium 1 · Japan 1 · Pennsylvania 1 · Puerto Rico 1 · Thailand 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-07-02 | EIR Pfizer Manufacturing Belgium NVJul 2, 2021 · Puurs, Belgium | Puurs, Belgium | — | |
| 2019-04-16 | 483 Sumitomo Pharma Co., Ltd.Apr 16, 2019 · Oita, Japan | Oita, Japan | 3 | |
| 2018-08-22 | 483 Central Admixture Pharmacy Services, Inc.Aug 22, 2018 · Allentown, Pennsylvania | Allentown, Pennsylvania | 8 | |
| 2018-03-23 | 483 NOVACYL (THAILAND) LIMITEDMar 23, 2018 · MUEANG SAMUT PRAKAN, Thailand | MUEANG SAMUT PRAKAN, Thailand | — | |
| 2016-08-18 | 483 SolvayAug 18, 2016 · Willow Island, West Virginia | Willow Island, West Virginia | 1 | |
| 2016-03-18 | 483 Pharmaceutics International, Inc.Mar 18, 2016 · Hunt Valley, Maryland | Hunt Valley, Maryland | 7 | |
| 2016-03-10 | 483 Pharmaceutics International IncMar 10, 2016 · Hunt Valley, Maryland | Hunt Valley, Maryland | 7 |
About this profile
What does Zhongren Wu inspect?
Zhongren Wu appears on 8 documents on file covering 7 sites, most often in Maryland.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.192 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 Zhongren Wu is dated Jul 2, 2021.