inforMED
FEI 3003387384

Phillips Precision Inc

7 Paul Kohner Pl, Elmwood Park, NJ, US

MDR events0All time
Recalls0All time
Registered products56
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)

Registered product codes

56 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 3003387384.

FDA inspections

2 on file

  • Official Action Indicated (OAI)Jul 17, 2024

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Jul 17, 2024

    Postmarket Assurance: Devices · Citations posted

Inspection citations

8 on file

  • 21 CFR 820.25(b)Jul 17, 2024

    Training - Lack of or inadequate procedures

  • 21 CFR 820.70(e)Jul 17, 2024

    Contamination control, Lack of or inadequate procedures

  • 21 CFR 820.70(g)(1)Jul 17, 2024

    Maintenance schedule, Lack of or inadequate schedule

  • 21 CFR 820.75(a)Jul 17, 2024

    Lack of or inadequate process validation

  • 21 CFR 820.75(b)Jul 17, 2024

    Lack/Inad procedure-Monitoring/Control of Validated Proces

  • 21 CFR 820.80(a)Jul 17, 2024

    Lack of or inadequate procedures - Acceptance activities

  • 21 CFR 820.90(a)Jul 17, 2024

    Nonconforming product, Lack of or inadequate procedures

  • 21 CFR 820.100(a)Jul 17, 2024

    Lack of or inadequate procedures

Import refusals

0 on file

No import refusals on file for this FEI number.