Company
TaiwanSyntec Scientific Corporation, Shenkang Hsiang, Changhua Hsien, Taiwan – FDA Inspections
Inspection records and compliance data for Syntec Scientific Corporation in Shenkang Hsiang, Changhua Hsien. 5 FDA inspections on record, 1 Form 483, last inspected March 26, 2026.
Company Profile
This profile covers Syntec Scientific Corporation based in Shenkang Hsiang, Changhua Hsien, Taiwan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 1, 2010. Last inspected March 26, 2026.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design validation - user needs and intended uses1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 26, 2026 | Not classified | Medical Devices & Rad Health | 1315936 |
| May 5, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1207360 |
| December 13, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1081598 |
| December 18, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 908743 |
| July 1, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 671677 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Syntec Scientific Corporation
FEI Number
3003414678
Address
Chuanshing Industrial Zone, No. 2 Kung San Road, Shenkang Hsiang, Changhua Hsien, -, Taiwan
Country
Taiwan
ID: b9fced07-7baa-4f28-8df9-60fcb2ceea09