FEI 3029926469
Sparrow Robot, Llc
4168 Fisher Road, Columbus, OH, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeRepackRepack or Relabel Medical Device
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 3029926469.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 10, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 10, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Apr 10, 2026
Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.1Apr 10, 2026
QMS not documented and maintained adequately
- ISO 13485:2016 Clause 7.1Apr 10, 2026
Processes needed for product realization not planned and developed
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.