Wendy G. Tan
FDA investigator · also recorded as A. Wendy Tan, Ip Wendy Tan
Appears on 11 documents from 2017 to 2023, most often at sites in Singapore. Most often cites control of microbiological contamination (21 CFR 211.113).
- 11
- Documents on file
- 5.7
- Observations per 483
- 2017
- First seen
- 2023
- Most recent
What they cite most
From 63 observations- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.192Production record review9
- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.160General requirements7
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.42Design and construction features4
Activity by year
2017: 2, 2020: 1, 2021: 1, 2022: 2, 2023: 5
Where
Singapore 2 · China 1 · Florida 1 · Germany 1 · Illinois 1 · Indiana 1
Often inspects with
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Inspection history
11 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-12-11 | 483 Human Genome Sciences, Inc.Dec 11, 2023 · Rockville, Maryland | Rockville, Maryland | 6 | |
| 2023-11-15 | 483 Catalent Indiana, LLCNov 15, 2023 · Bloomington, Indiana | Bloomington, Indiana | 6 | |
| 2023-05-26 | 483 Suzhou Union Biopharm Co., Ltd.May 26, 2023 · Suzhou, China | Suzhou, China | 3 | |
| 2023-03-22 | 483 Rentschler Biopharma Inc.Mar 22, 2023 · Milford, Massachusetts | Milford, Massachusetts | 6 | |
| 2023-03-07 | 483 Rentschler Biopbanna SEMar 7, 2023 · Laupheim, Germany | Laupheim, Germany | 5 | |
| 2022-08-01 | 483 Roche Singapore Technical Operations Pte. Ltd.Aug 1, 2022 · Singapore, Singapore | Singapore, Singapore | 6 | |
| 2022-01-14 | 483 Kashiv BioSciences, LLCJan 14, 2022 · Chicago, Illinois | Chicago, Illinois | 5 |
About this profile
What does Wendy G. Tan inspect?
Wendy G. Tan appears on 11 documents on file covering 11 sites, most often in Singapore.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.100.
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 Wendy G. Tan is dated Dec 11, 2023.