Company
TaiwanBiotest Medical Corp, Taichung City, Taiwan – FDA Inspections
Inspection records and compliance data for Biotest Medical Corp in Taichung City. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 30, 2017.
Company Profile
This profile covers Biotest Medical Corp based in Taichung City, Taiwan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 18, 2010. Last inspected March 30, 2017.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Equipment Installation, Placement, Specified Requirements1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 30, 2017 | Not classified | Medical Devices & Rad Health | 1008493 |
| May 15, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 882571 |
| November 18, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 704675 |
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
Biotest Medical Corp
FEI Number
3004644399
Address
No. 3-2 Chien-Kou Road, Tepz Tantzu, Taichung City, Taiwan
Country
Taiwan
ID: 7d709739-60cb-445e-82a3-23a95a485ca0