Cynthia Jim
FDA investigator · also recorded as Pe Cynthia Jim
Appears on 20 documents from 2012 to 2024, most often at sites in North Carolina. Most often cites control of microbiological contamination (21 CFR 211.113).
- 20
- Documents on file
- 11.1
- Observations per 483
- 2012
- First seen
- 2024
- Most recent
What they cite most
From 193 observations- 21 CFR 211.113Control of microbiological contamination24
- 21 CFR 211.160General requirements24
- 21 CFR 211.192Production record review24
- 21 CFR 211.42Design and construction features15
- 21 CFR 211.100Written procedures; deviations12
- 21 CFR 211.165Testing and release for distribution11
Activity by year
2012: 1, 2013: 1, 2015: 2, 2016: 2, 2017: 1, 2018: 4, 2019: 3, 2021: 1, 2022: 4, 2024: 1
Where
North Carolina 4 · India 3 · United Kingdom 3 · California 2 · Pennsylvania 2 · Florida 1
Often inspects with
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Inspection history
20 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-04-26 | 483 BIOLOGICAL E. LIMITEDApr 26, 2024 · Medchal, India | Medchal, India | 6 | |
| 2022-12-14 | 483 Kyowa Kirin Co., Ltd.Dec 14, 2022 · Takasaki-shi, Japan | Takasaki-shi, Japan | 13 | |
| 2022-10-14 | 483 Lupin Limited (Biotech Division)Oct 14, 2022 · Pune, India | Pune, India | 11 | |
| 2022-06-20 | 483 Immacule Lifesciences Private LimitedJun 20, 2022 · Nalagarh, India | Nalagarh, India | 8 | |
| 2022-03-17 | 483 Alvotech HfMar 17, 2022 · Reykjavík, Iceland | Reykjavík, Iceland | 13 | |
| 2021-05-04 | 483 INDUSTRIA FARMACEUTICA GALENICA SENESE SRLMay 4, 2021 · MONTERONI D'ARBIA, Italy | MONTERONI D'ARBIA, Italy | — | |
| 2019-10-25 | 483 Stason Pharmaceuticals. IncOct 25, 2019 · Irvine, California | Irvine, California | 15 |
About this profile
What does Cynthia Jim inspect?
Cynthia Jim appears on 20 documents on file covering 18 sites, most often in North Carolina.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.160 and 21 CFR 211.192.
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 Cynthia Jim is dated Apr 26, 2024.