FEI 3017838287
Operating Room Innovations, Inc
2223 Avenida De La Playa, La Jolla, CA, US
MDR events1All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
1 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 3017838287.
FDA inspections
2 on file
- Official Action Indicated (OAI)May 22, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 22, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(i)May 22, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50May 22, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)May 22, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)May 22, 2025
Lack of or inadequate complaint procedures
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.