FEI 1000488948
Protech Leaded Eyewear, Inc.
7960 Central Industrial Drive, West Palm Beach, FL, US
MDR events1All time
Recalls0All time
Registered products5
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
5 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000488948.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 10, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 10, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Mar 10, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Mar 10, 2025
Design control - no procedures
- 21 CFR 820.198(a)Mar 10, 2025
Complaints
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.