Wissner-bosserhoff Gmbh
Hauptstrasse 4-6, Wickede (Ruhr) North Rhine-Westphalia, DE
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Compliance history
Matched by FEI 3015979371.
FDA inspections
3 on file
- Official Action Indicated (OAI)Apr 25, 2024
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Apr 25, 2024
Postmarket Assurance: Devices · Citations posted
- Official Action Indicated (OAI)Apr 25, 2024
Project Evaluation: Devices · Citations posted
Inspection citations
10 on file
Top cited requirements
Compare to industry ↗21 CFR 806.20(b)(4)Justification for not reporting
121 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.30(d)Design output - documentation
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
121 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
1
- 21 CFR 806.20(b)(4)Apr 25, 2024
Justification for not reporting
- 21 CFR 820.20(c)Apr 25, 2024
Management review - Lack of or inadequate procedures
- 21 CFR 820.30(d)Apr 25, 2024
Design output - documentation
- 21 CFR 820.30(i)Apr 25, 2024
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Apr 25, 2024
Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(a)(1)Apr 25, 2024
Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(a)Apr 25, 2024
Production processes
- 21 CFR 820.70(i)Apr 25, 2024
Documentation of software validation
- 21 CFR 820.80(b)Apr 25, 2024
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(b)Apr 25, 2024
Documentation
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.