Company
TaiwanEPS Bio Technology Corp., Hsinchu, Taiwan – FDA Inspections
Inspection records and compliance data for EPS Bio Technology Corp. in Hsinchu. 5 FDA inspections on record (1 OAI), 2 Form 483s, last inspected January 15, 2026.
Company Profile
This profile covers EPS Bio Technology Corp. based in Hsinchu, Taiwan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 21, 2012. Last inspected January 15, 2026.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of procedures, or not maintained1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 15, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1299020 |
| October 26, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1227391 |
| January 8, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1116987 |
| July 26, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 845943 |
| June 21, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 789179 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
EPS Bio Technology Corp.
FEI Number
3004130086
Address
No. 8, R&D Rd. Iii, Hsinchu Science Park, Hsinchu, Taiwan
Country
Taiwan
ID: bb3026bd-46a6-4a6f-b8e0-2bbc1adfe0fb