Ko U. Min
View detailed information about Ko U. Min, including compliance records, violations, and related data.
FDA investigator, Department of Health and Human Services. Took part in 7 inspections of 7 companies, 2017–2023.
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| January 13, 2023 | PPL Healthcare LLC | VAI | Drug Quality Assurance | #1195198 |
| August 30, 2018 | Akorn Operating Company LLC | Not classified | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1064286 |
| June 8, 2018 | Advanced Accelerator Applications (Italy) S.r.l. | VAI | Drug Quality Assurance | #1055374 |
| April 12, 2018 | Viatris Inc. | OAI | Generic Drug Evaluation | #1047915 |
| November 16, 2017 | Pharmaceutics International Inc | VAI | Generic Drug Evaluation | #1031480 |
| July 21, 2017 | Lonza Bend Inc. | VAI | Drug Quality Assurance | #1018924 |
| May 25, 2017 | Pharmaceutical Manufacturing Research Services, Inc (PMRS) | Not classified | New Drug Evaluation | #1015444 |
- 483 · Viatris Inc. · April 12, 2018
- 483 · Novel Laboratories, Inc. d.b.a Lupin Somerset · March 30, 2022
- 483 · Novel Laboratories, Inc. d.b.a Lupin Somerset · November 5, 2020
- 483 · Akorn Operating Company LLC · May 17, 2022
- 483 · Pharmaceutics International Inc · November 16, 2017
- 483 · Samjan Group, Inc. · March 3, 2022
- 483 · WuXi Advanced Therapies · April 17, 2015
- 483 · Aurolife Pharma, LLC · December 7, 2021
- 483 · Viatris Inc. · May 26, 2022
- 483 · Guardian Drug Co. Inc. · February 17, 2022
- 483 · Pharmaceutical Manufacturing Research Services, Inc (PMRS) · May 25, 2017
- EIR · WuXi Advanced Therapies · April 17, 2015
- 483 · Akorn Operating Company LLC · August 30, 2018
- 483 · ImClone Systems, LLC · August 21, 2020
Supervisory Consumer Safety Officer, China Office
Staff Director
Consumer Safety Officer
Consumer Safety Officer (Inspector)
PreApproval Manager
Investigator
Investigator
Name
Ko U. Min
Title
Consumer Safety Officer at FDA U.S. Food and Drug Administration
Role
Regulatory Personnel
ID: 9bb5f33e-857b-4c6f-a550-fdb439760e30
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