Company
Korea (the Republic of)Kolmar Korea Co. Ltd., Sejong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Kolmar Korea Co. Ltd. in Sejong. 4 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected July 05, 2019.
Company Profile
This profile covers Kolmar Korea Co. Ltd. based in Sejong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected July 12, 2013. Last inspected July 5, 2019.
Most cited issue areas
- Scientifically sound laboratory controls2 inspections
- Training--operations, GMPs, written procedures2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 5, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1095865 |
| September 28, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1028265 |
| April 3, 2015 | VAI | Human Drugs · Drug Quality Assurance | 923033 |
| July 12, 2013 | VAI | Human Drugs · Drug Quality Assurance | 842594 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kolmar Korea Co. Ltd.
FEI Number
3004033751
Address
245 Sandan-Gil, Jeonui-Myeon, Sejong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 1593ea1f-ab89-4e5c-852b-2ccd0ce714af