FEI 1000126034
Simpex Medical, Inc.
1974 Carolina Place Drive, Fort Mill, SC, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
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 1000126034.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 28, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jun 28, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(b)Jun 28, 2024
Design plans - Lack of or inadequate
- 21 CFR 820.72(a)Jun 28, 2024
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Jun 28, 2024
Lack of or inadequate process validation
- 21 CFR 820.120(b)Jun 28, 2024
DHR documentation of label release {see also 820.184}
- 21 CFR 820.250(b)Jun 28, 2024
Sampling plans
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.