FEI 3012121190
Carrashield Labs, Inc.
1876 Coffee Pot Blvd NE, Saint Petersburg, FL, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
1 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3012121190.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 29, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 29, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 801.20(a)Apr 29, 2026
Label to bear a unique device identifier
- ISO 13485:2016 Clause 7.3.3Apr 29, 2026
Design and development inputs do not include all requirements
- ISO 13485:2016 Clause 7.3.6Apr 29, 2026
Design and development verification not performed
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.