inforMED
FEI 3004824601

Asp Global, Llc

7800 Third Flag Pkwy, Austell, GA, US

MDR events2All time
Recalls25All time
Registered products60
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

60 product codes

Recalls

25 on file

Compliance history

Matched by FEI 3004824601.

FDA inspections

2 on file

  • Official Action Indicated (OAI)Aug 1, 2025

    Compliance: Devices · Citations posted

  • Official Action Indicated (OAI)Aug 1, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

3 on file

  • 21 CFR 803.50(a)(1)Aug 1, 2025

    Report of Death or Serious Injury

  • 21 CFR 806.10(a)(1)Aug 1, 2025

    Report of risk to health

  • 21 CFR 820.50Aug 1, 2025

    Purchasing controls, Lack of or inadequate procedures

Import refusals

1 on file

  • Division of Southeast Imports (DSEI)Feb 13, 2025

    73BZG \ SPIROMETER, DIAGNOSTIC