R.g. Enterprises (u.s.a.), Inc.
26010 Pinehurst Dr, Madison Heights, MI, US
Registered product codes
2 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 1000518606.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 5, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Nov 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
9 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.30(a)Design control - no procedures
121 CFR 820.30(j)Design history file
121 CFR 820.40Lack of procedures, or not maintained
1
- 21 CFR 803.17Nov 5, 2025
Lack of Written MDR Procedures
- 21 CFR 820.20(c)Nov 5, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Nov 5, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Nov 5, 2025
Design control - no procedures
- 21 CFR 820.30(j)Nov 5, 2025
Design history file
- 21 CFR 820.40Nov 5, 2025
Lack of procedures, or not maintained
- 21 CFR 820.50Nov 5, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nov 5, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Nov 5, 2025
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.