inforMED
FEI 3001814065

Creative Foam Corporation - Bremen

405 Industrial Dr, BREMEN, IN, US

MDR events0All time
Recalls0All time
Registered products7
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)

Registered product codes

7 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 3001814065.

FDA inspections

1 on file

  • Voluntary Action Indicated (VAI)Nov 24, 2025

    Compliance: Devices · Citations posted

Inspection citations

8 on file

  • 21 CFR 820.70(g)(1)Nov 24, 2025

    Maintenance schedule, Lack of or inadequate schedule

  • 21 CFR 820.72(a)Nov 24, 2025

    Calibration, Inspection, etc. Procedures Lack of or Inadequ

  • 21 CFR 820.75(a)Nov 24, 2025

    Lack of or inadequate process validation

  • 21 CFR 820.75(b)Nov 24, 2025

    Lack/Inad procedure-Monitoring/Control of Validated Proces

  • 21 CFR 820.90(a)Nov 24, 2025

    Nonconforming product, Lack of or inadequate procedures

  • 21 CFR 820.100(a)Nov 24, 2025

    Lack of or inadequate procedures

  • 21 CFR 820.198(a)Nov 24, 2025

    Lack of or inadequate complaint procedures

  • 21 CFR 820.250(b)Nov 24, 2025

    Sampling plans

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.