FEI 3014151865
Aerobiotix Usa
444 Alexandersville Rd, Miamisburg, OH, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device
Registered product codes
3 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 3014151865.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 11, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 11, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(b)(2)Apr 11, 2024
Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.100(a)Apr 11, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(c)Apr 11, 2024
Investigation of device failures
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.