Daniels Manufacturing Operations Inc.
3600 South Memorial Drive, Racine, WI, US
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 3012630624.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Nov 8, 2023
Compliance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(a)Management ensuring quality policy is understood
121 CFR 820.20(c)Management review - defined interval, sufficient frequency
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
121 CFR 820.100(b)Documentation
1
- 21 CFR 820.20(a)Nov 8, 2023
Management ensuring quality policy is understood
- 21 CFR 820.20(c)Nov 8, 2023
Management review - defined interval, sufficient frequency
- 21 CFR 820.22Nov 8, 2023
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.40Nov 8, 2023
Procedures not adequately established or maintained
- 21 CFR 820.72(a)Nov 8, 2023
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.100(b)Nov 8, 2023
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.