inforMED
FEI 3010041993

Precision Forms, Inc.

97 Decker Rd, Butler, NJ, US

MDR events0All time
Recalls0All time
Registered products17
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)

Registered product codes

17 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 3010041993.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)May 1, 2025

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)May 1, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

3 on file

  • 21 CFR 820.75(a)May 1, 2025

    Lack of or inadequate process validation

  • 21 CFR 820.75(b)May 1, 2025

    Lack/Inad procedure-Monitoring/Control of Validated Proces

  • 21 CFR 820.100(a)May 1, 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.