World Source Simple Llc.
2411 Shawnee Rd, Lima, OH, 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 3014527907.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 10, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 10, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
1ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
1ISO 13485:2016 Clause 5.1Lack of evidence for top management's commitment to QMS
1ISO 13485:2016 Clause 6.2Personnel competency not adequate
1ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
1
- 21 CFR 803.17Mar 10, 2026
Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.1Mar 10, 2026
QMS not documented and maintained adequately
- ISO 13485:2016 Clause 5.1Mar 10, 2026
Lack of evidence for top management's commitment to QMS
- ISO 13485:2016 Clause 6.2Mar 10, 2026
Personnel competency not adequate
- ISO 13485:2016 Clause 8.2.2Mar 10, 2026
Complaint handling procedures not documented
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.