Company
Korea (the Republic of)Bio Focus Co. Ltd., Uiwang-si, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Bio Focus Co. Ltd. in Uiwang-si. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected February 26, 2015.
Company Profile
This profile covers Bio Focus Co. Ltd. based in Uiwang-si, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected April 17, 2013. Last inspected February 26, 2015.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Lack of or inadequate In-process acceptance procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 26, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 918396 |
| April 17, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 836155 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bio Focus Co. Ltd.
FEI Number
3005841978
Address
Deahyun Technoworld, Ojeon-dong, Uiwang-si, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 930b1b99-feb6-4403-9962-19074c37becd