Company
TaiwanBioteque Taiwan Ltd., New Taipei City, Taiwan – FDA Inspections
Inspection records and compliance data for Bioteque Taiwan Ltd. in New Taipei City. 4 FDA inspections on record, 2 Form 483s, last inspected January 23, 2020.
Company Profile
This profile covers Bioteque Taiwan Ltd. based in New Taipei City, Taiwan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 3, 2014. Last inspected January 23, 2020.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 23, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1118749 |
| December 8, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 995273 |
| December 8, 2016 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 995272 |
| April 3, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 877305 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bioteque Taiwan Ltd.
FEI Number
3003968049
Address
7F., No. 431,433, Baozhang Rd., Xizhi District, New Taipei City, Taiwan
Country
Taiwan
ID: 13dde226-5e6f-4a39-869a-49bfc9ae640c