inforMED
FEI 3017375560Initial importer

Integrity United Inc Dba Costcare

4989 E La Palma Ave, Anaheim, CA, US

MDR events0All time
Recalls0All time
Registered products10
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198

Registered product codes

10 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 3017375560.

FDA inspections

2 on file

  • Official Action Indicated (OAI)Sep 25, 2025

    Compliance: Devices · Citations posted

  • Official Action Indicated (OAI)Sep 25, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

9 on file

  • 21 CFR 801.20(a)Sep 25, 2025

    Label to bear a unique device identifier

  • 21 CFR 820.20(c)Sep 25, 2025

    Management review - Lack of or inadequate procedures

  • 21 CFR 820.22Sep 25, 2025

    Quality audits - Lack of or inadequate procedures

  • 21 CFR 820.30(j)Sep 25, 2025

    Design history file

  • 21 CFR 820.40Sep 25, 2025

    Lack of procedures, or not maintained

  • 21 CFR 820.50Sep 25, 2025

    Purchasing controls, Lack of or inadequate procedures

  • 21 CFR 820.100(b)Sep 25, 2025

    Documentation

  • 21 CFR 820.184Sep 25, 2025

    Lack of or inadequate DHR procedures

  • 21 CFR 820.198(a)Sep 25, 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.