inforMED
FEI 1000550978

Marson Medical, Inc.

E-64 MIDLAND AVE., PARAMUS, NJ, US

MDR events0All time
Recalls0All time
Registered products12
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)

Registered product codes

12 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 1000550978.

FDA inspections

2 on file

  • Official Action Indicated (OAI)Jan 16, 2026

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Jan 16, 2026

    Postmarket Assurance: Devices · Citations posted

Inspection citations

11 on file

  • 21 CFR 820.22Jan 16, 2026

    Quality audits - auditor independence

  • 21 CFR 820.25(b)Jan 16, 2026

    Training - Lack of or inadequate procedures

  • 21 CFR 820.40Jan 16, 2026

    Procedures not adequately established or maintained

  • 21 CFR 820.70(a)Jan 16, 2026

    Process control procedures, Lack of or inadequate procedures

  • 21 CFR 820.75(a)Jan 16, 2026

    Lack of or inadequate process validation

  • 21 CFR 820.75(b)Jan 16, 2026

    Lack/Inad procedure-Monitoring/Control of Validated Proces

  • 21 CFR 820.90(a)Jan 16, 2026

    Nonconforming product, Lack of or inadequate procedures

  • 21 CFR 820.100(a)Jan 16, 2026

    Lack of or inadequate procedures

  • 21 CFR 820.184Jan 16, 2026

    Lack of or inadequate DHR procedures

  • 21 CFR 820.198(a)Jan 16, 2026

    Lack of or inadequate complaint procedures

  • 21 CFR 820.250(b)Jan 16, 2026

    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.