FEI 1831638
Richard-allan Scientific Llc
4481 CAMPUS DR., KALAMAZOO, MI, US
MDR events0All time
Recalls0All time
Registered products59
Establishment typeManufactureManufacture Medical Device
Registered product codes
59 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 1831638.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 23, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 23, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(2)Apr 23, 2025
Individual Report of Malfunction
- 21 CFR 820.75(c)Apr 23, 2025
Process changes - review, evaluation and revalidation
- 21 CFR 820.250(b)Apr 23, 2025
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.