Lisa Shin
FDA investigator · also recorded as Ae Lisa Shin, Ss Ths Lisa Shin
Appears on 13 documents from 2020 to 2023, mostly at sites in California. Most often cites production record review (21 CFR 211.192).
- 13
- Documents on file
- 6.0
- Observations per 483
- 2020
- First seen
- 2023
- Most recent
What they cite most
From 78 observations- 21 CFR 211.192Production record review10
- 21 CFR 211.68Automatic, mechanical, and electronic equipment10
- 21 CFR 211.160General requirements9
- 21 CFR 211.67Equipment cleaning and maintenance8
- 21 CFR 211.194Laboratory records7
- 21 CFR 211.22Responsibilities of quality control unit7
Activity by year
2020: 3, 2021: 4, 2022: 5, 2023: 1
Where
California 7 · Mexico 2 · Switzerland 1 · Tennessee 1 · Utah 1 · Wyoming 1
Often inspects with
Claudia M. Perez-Kasmarski· Uttaniti Limchumroon· Joel D. Hustedt
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Inspection history
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-04-04 | 483 Similasan AGApr 4, 2023 · Jonen, Switzerland | Jonen, Switzerland | 4 | |
| 2022-11-04 | 483 Yusef Manufacturing Laboratories, LLCNov 4, 2022 · Clearfield, Utah | Clearfield, Utah | 12 | |
| 2022-09-13 | 483 KDC/ONE SOCAL LABORATORIES, LLCSep 13, 2022 · Walnut, California | Walnut, California | 4 | |
| 2022-04-15 | 483 Form 483 · FEI 3002808161Apr 15, 2022 · Toluca, Mexico | Toluca, Mexico | 6 | |
| 2022-04-08 | 483 Form 483 · FEI 3004641553Apr 8, 2022 · Naucalpan de Juarez, Mexico | Naucalpan de Juarez, Mexico | 2 | |
| 2022-03-07 | 483 Green Wave Analytical, LLCMar 7, 2022 · San Diego, California | San Diego, California | 7 | |
| 2021-12-03 | 483 Wedgewood Connect, LLCDec 3, 2021 · San Jose, California | San Jose, California | 4 |
About this profile
What does Lisa Shin inspect?
Lisa Shin appears on 13 documents on file covering 13 sites, mostly in California.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.68 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 Lisa Shin is dated Apr 4, 2023.