Company
Korea (the Republic of)Bio Protech, Inc., Wonju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Bio Protech, Inc. in Wonju. 3 FDA inspections on record, 1 Form 483, last inspected April 09, 2026.
Company Profile
This profile covers Bio Protech, Inc. based in Wonju, 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 December 9, 2010. Last inspected April 9, 2026.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures for storage.1 inspection
- Monitoring/measurement methods do not show QMS processes meet planned results1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 9, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1318198 |
| March 23, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977719 |
| December 9, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 704336 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bio Protech, Inc.
FEI Number
3003514332
Address
Donghwa Medical Instrument Complex, 1654-7 Donghwa-Ri Munmak-Eup, Wonju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 6be640bc-59c4-4c6d-aa5b-a4c13a1e99f9