Bioteque America, Inc.
1302 Exchange Drive, Suite # 150, Richardson, TX, US
Registered product codes
6 product codes
Recent MDR events
2 on file
Compliance history
Matched by FEI 3024860690.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 23, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 23, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 830.310(b)GUDID Information required for unique device identification.
1
- 21 CFR 803.17Apr 23, 2025
Lack of Written MDR Procedures
- 21 CFR 820.30(g)Apr 23, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Apr 23, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Apr 23, 2025
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(a)Apr 23, 2025
Lack of or inadequate procedures
- 21 CFR 830.310(b)Apr 23, 2025
GUDID Information required for unique device identification.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.