Company
TaiwanBioteque Corporation I-Lan Factory II, Su-Ao Cheng, Taiwan – FDA Inspections
Inspection records and compliance data for Bioteque Corporation I-Lan Factory II in Su-Ao Cheng. 4 FDA inspections on record, 1 Form 483, last inspected June 12, 2025.
Company Profile
This profile covers Bioteque Corporation I-Lan Factory II based in Su-Ao Cheng, Taiwan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 23, 2012. Last inspected June 12, 2025.
Most cited issue areas
- Document review, approval documentation1 inspection
- Equipment suitability & capability1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 12, 2025 | Not classified | Medical Devices & Rad Health | 1264423 |
| August 2, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1065864 |
| July 15, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 989089 |
| August 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 800604 |
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
Bioteque Corporation I-Lan Factory II
FEI Number
3004207966
Address
No. 5 Chung Cheng Road, Su-Ao Cheng, Taiwan
Country
Taiwan
ID: 37b7849a-5af0-4c9c-9e4b-b43b67027624