FEI 3006606837
Halo Dream, Inc.
213 West 35th Street, Suite 12W, New York, NY, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
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 3006606837.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 6, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 6, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(b)Dec 6, 2024
Design plans - Lack of or inadequate
- 21 CFR 820.30(f)Dec 6, 2024
Design verification - documentation
- 21 CFR 820.100(b)Dec 6, 2024
Documentation
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.