Della Shin
FDA investigator
Appears on 3 documents from 2024 to 2025, most often at sites in California. Most often cites control of microbiological contamination (21 CFR 211.113).
- 3
- Documents on file
- 6.3
- Observations per 483
- 2024
- First seen
- 2025
- Most recent
What they cite most
From 19 observations- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.100Written procedures; deviations2
Activity by year
2024: 2, 2025: 1
Where
California 1 · Iceland 1 · South Korea 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-07-04 | 483 Alvotech HfJul 4, 2025 · Reykjavik, Iceland | Reykjavik, Iceland | 10 | |
| 2024-06-20 | 483 Binex Co., LtdJun 20, 2024 · Incheon, South Korea | Incheon, South Korea | 4 | |
| 2024-02-06 | 483 Amgen, IncFeb 6, 2024 · Thousand Oaks, California | Thousand Oaks, California | 5 |
About this profile
What does Della Shin inspect?
Della Shin appears on 3 documents on file covering 3 sites, most often in California.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), 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 Della Shin is dated Jul 4, 2025.