Company
Korea (the Republic of)Kolmar Korea Co., Ltd. - Gwanjeong Factory, Chungcheongnam-Do, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Kolmar Korea Co., Ltd. - Gwanjeong Factory in Chungcheongnam-Do. 3 FDA inspections on record, last inspected February 16, 2024.
Company Profile
This profile covers Kolmar Korea Co., Ltd. - Gwanjeong Factory based in Chungcheongnam-Do, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 15, 2017. Last inspected February 16, 2024.
Most cited issue areas
- Acceptance of drug products1 inspection
- Adequate number of batches on stability1 inspection
- Batch production and Batch Control Record Requirements1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1230224 |
| July 7, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1173870 |
| September 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1031995 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kolmar Korea Co., Ltd. - Gwanjeong Factory
FEI Number
3010299845
Address
22-17, Sandan-Gil, Jeonui-Myeon, Sejong-Si, Chungcheongnam-Do, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 392855b3-652a-43a6-abb2-d78b2b634c5e