Ko U. Min
FDA investigator
Appears on 13 documents from 2017 to 2023, mostly at sites in New Jersey. Most often cites general requirements (21 CFR 211.160).
- 13
- Documents on file
- 8.0
- Observations per 483
- 2017
- First seen
- 2023
- Most recent
What they cite most
From 103 observations- 21 CFR 211.160General requirements18
- 21 CFR 211.192Production record review15
- 21 CFR 211.67Equipment cleaning and maintenance13
- 21 CFR 211.68Automatic, mechanical, and electronic equipment8
- 21 CFR 211.22Responsibilities of quality control unit6
- 21 CFR 211.100Written procedures; deviations5
Activity by year
2017: 2, 2018: 2, 2020: 3, 2021: 2, 2022: 3, 2023: 1
Where
New Jersey 9 · Pennsylvania 2 · Maryland 1 · West Virginia 1
Often inspects with
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Inspection history
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-01-13 | 483 PEL Healthcare LLCJan 13, 2023 · Sellersville, Pennsylvania | Sellersville, Pennsylvania | 1 | |
| 2022-05-17 | 483 Akorn Operating Company LLC (dba Akorn)May 17, 2022 · Somerset, New Jersey | Somerset, New Jersey | — | |
| 2022-03-30 | 483 Novel Laboratories , Inc. d.b . a Lupin Somerset 'Mar 30, 2022 · Somerset, New Jersey | Somerset, New Jersey | 13 | |
| 2022-02-17 | 483 Guardian Drug Co. IncFeb 17, 2022 · Dayton, New Jersey | Dayton, New Jersey | 7 | |
| 2021-12-07 | 483 Aurolife Pharma LLCDec 7, 2021 · Dayton, New Jersey | Dayton, New Jersey | 9 | |
| 2021-06-29 | 483 Carnegie Pharmaceuticals, LLCJun 29, 2021 · Delran, New Jersey | Delran, New Jersey | 3 | |
| 2020-11-05 | 483 Novel Laboratories, Inc.Nov 5, 2020 · Somerset, New Jersey | Somerset, New Jersey | 13 |
About this profile
What does Ko U. Min inspect?
Ko U. Min appears on 13 documents on file covering 11 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.192 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 Ko U. Min is dated Jan 13, 2023.