Hyung Lee
FDA investigator
Appears on 1 document from 2023, mostly at sites in India. Most often cites general requirements (21 CFR 211.160).
- 1
- Documents on file
- 7.0
- Observations per 483
- 2023
- First seen
- 2023
- Most recent
What they cite most
From 7 observations- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
Activity by year
2023: 1
Where
India 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-12-07 | 483 Intas Pharmaceuticals LimitedDec 7, 2023 · Ahmedabad, India | Ahmedabad, India | 7 |
About this profile
What does Hyung Lee inspect?
Hyung Lee appears on 1 document on file covering 1 site, mostly in India.
What do they cite most often?
21 CFR 211.160 (general requirements), 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 Hyung Lee is dated Dec 7, 2023.