Company
Korea (the Republic of)Vassen Co. Ltd., Pyeongtaek, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Vassen Co. Ltd. in Pyeongtaek. 3 FDA inspections on record, 1 Form 483, last inspected May 14, 2026.
Company Profile
This profile covers Vassen Co. Ltd. based in Pyeongtaek, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 29, 2015. Last inspected May 14, 2026.
Most cited issue areas
- Inadequate monitoring and control over outsourced processes1 inspection
- Lack of Written MDR Procedures1 inspection
- Procedures to control design and development changes not documented1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1320332 |
| December 14, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1226905 |
| October 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 948870 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Vassen Co. Ltd.
FEI Number
3008034930
Address
(Ju)Inteohogeun, 50 Seotan-Ro; Jinwi-Myeon, Pyeongtaek, Korea (the Republic of)
Country
Korea (the Republic of)
ID: e66850cc-83a6-41b7-99ef-0b82420bd8fd