inforMED
FEI 1922538

Penner Patient Care, Inc

101 Grant St, Aurora, NE, US

MDR events1All time
Recalls10All time
Registered products1
Establishment typeManufactureManufacture Medical Device

Registered product codes

1 product codes

Recent MDR events

1 on file

Recalls

10 on file

Compliance history

Matched by FEI 1922538.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Feb 11, 2025

    Compliance: Devices · Citations posted

  • Voluntary Action Indicated (VAI)Feb 11, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

4 on file

Top cited requirements

Compare to industry ↗
  • 21 CFR 801.20(a)Feb 11, 2025

    Label to bear a unique device identifier

  • 21 CFR 803.17(a)(3)Feb 11, 2025

    Lack of System for Timely Submission of Reports

  • 21 CFR 820.50(a)Feb 11, 2025

    Evaluation of suppliers, contractors, etc., requirements

  • 21 CFR 820.100(a)Feb 11, 2025

    Lack of or inadequate 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.