Hoosier, Inc.
1140 California Ave, Corona, CA, US
Registered product codes
15 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 3003058119.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Aug 21, 2025
Compliance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.80(b)Incoming acceptance records, documentation
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Complaints
1
- 21 CFR 820.50Aug 21, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Aug 21, 2025
Lack of or inadequate process validation
- 21 CFR 820.80(a)Aug 21, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(b)Aug 21, 2025
Incoming acceptance records, documentation
- 21 CFR 820.100(a)Aug 21, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Aug 21, 2025
Complaints
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.