Jee Y. Chung
FDA investigator
Appears on 5 documents from 2013 to 2023, most often at sites in Massachusetts. Most often cites written procedures; deviations (21 CFR 211.100).
- 5
- Documents on file
- 4.4
- Observations per 483
- 2013
- First seen
- 2023
- Most recent
What they cite most
From 22 observations- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements5
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.192Production record review3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
Activity by year
2013: 1, 2017: 1, 2019: 2, 2023: 1
Where
Massachusetts 2 · California 1 · Maryland 1 · North Carolina 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-02-10 | 483 FUJIFILM Diosynth Biotechnologies U.S.A., IncFeb 10, 2023 · North Carolina | North Carolina | 3 | |
| 2019-01-18 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCJan 18, 2019 · Andover, Massachusetts | Andover, Massachusetts | 1 | |
| 2019-01-17 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCJan 17, 2019 · Andover, Massachusetts | Andover, Massachusetts | 2 | |
| 2017-05-16 | 483 Amgen, IncMay 16, 2017 · Thousand Oaks, California | Thousand Oaks, California | 5 | |
| 2013-04-26 | 483 Human Genome Sciences, Inc.Apr 26, 2013 · Rockville, Maryland | Rockville, Maryland | 11 |
About this profile
What does Jee Y. Chung inspect?
Jee Y. Chung appears on 5 documents on file covering 4 sites, most often in Massachusetts.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.160 and 21 CFR 211.67.
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 Jee Y. Chung is dated Feb 10, 2023.