inforMED
FEI 3024991168

Audicon Corporation

3602 Inland Empire, Ontario, CA, US

MDR events0All time
Recalls0All time
Registered products3
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

3 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 3024991168.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Aug 8, 2025

    Compliance: Devices · Citations posted

  • Voluntary Action Indicated (VAI)Aug 8, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

4 on file

  • 21 CFR 820.100(a)Aug 8, 2025

    Lack of or inadequate procedures

  • 21 CFR 803.17Aug 8, 2025

    Lack of Written MDR Procedures

  • 21 CFR 820.25(b)Aug 8, 2025

    Training - Lack of or inadequate procedures

  • 21 CFR 820.198(a)Aug 8, 2025

    Lack of or inadequate complaint 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.