Atz Manufacturing
1105 Lake Rd, Marshall, MN, 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 3014653196.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 24, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jul 24, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
9 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 820.20(e)Quality System Procedures
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(a)Production processes
121 CFR 820.100(a)Lack of or inadequate procedures
1
- 21 CFR 801.20(a)Jul 24, 2025
Label to bear a unique device identifier
- 21 CFR 820.20(e)Jul 24, 2025
Quality System Procedures
- 21 CFR 820.25(b)Jul 24, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.50Jul 24, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Jul 24, 2025
Production processes
- 21 CFR 820.100(a)Jul 24, 2025
Lack of or inadequate procedures
- 21 CFR 820.184Jul 24, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Jul 24, 2025
Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Jul 24, 2025
Servicing - 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.