Company
Korea (the Republic of)Eone Laboratories, Yeonsu, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Eone Laboratories in Yeonsu. 3 FDA inspections on record, 2 Form 483s, last inspected September 23, 2025.
Company Profile
This profile covers Eone Laboratories based in Yeonsu, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 9, 2019. Last inspected September 23, 2025.
Most cited issue areas
- Records incomplete2 inspections
- Documentation of use1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 23, 2025 | Not classified | Biologics | 1294048 |
| August 30, 2023 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1216308 |
| April 9, 2019 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1086218 |
FDA documents
Form 483s (2)
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Company Information
Name
Eone Laboratories
FEI Number
3012094568
Address
49 Songdong, Yeonsu, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 3f316442-252e-42df-b9bd-548bd062a6f4