FEI 3000957797
Advanced Instrumentations, Inc.
6800 NW 77TH COURT, Miami, FL, US
MDR events1All time
Recalls0All time
Registered products45
Establishment typeManufactureManufacture Medical Device
Registered product codes
45 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 3000957797.
FDA inspections
3 on file
- Official Action Indicated (OAI)Apr 17, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 26, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 26, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(a)Apr 17, 2025
Management ensuring quality policy is understood
- 21 CFR 820.30(j)Apr 17, 2025
Design history file
- 21 CFR 820.40Apr 17, 2025
Procedures not adequately established or maintained
- 21 CFR 820.50Apr 17, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(a)Apr 17, 2025
Complaints
- 21 CFR 820.30(j)Feb 26, 2024
Design history file
- 21 CFR 820.40Feb 26, 2024
Procedures not adequately established or maintained
- 21 CFR 820.50Feb 26, 2024
Purchasing controls, Lack of or inadequate 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.