inforMED
FEI 1000147357

General Physiotherapy Ii Llc

3683 New Town Blvd, Saint Charles, MO, US

MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device

Registered product codes

2 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 1000147357.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Mar 12, 2025

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Mar 12, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

5 on file

  • 21 CFR 801.20(a)Mar 12, 2025

    Label to bear a unique device identifier

  • 21 CFR 820.22Mar 12, 2025

    Quality Audit/Reaudit - conducted

  • 21 CFR 820.50Mar 12, 2025

    Purchasing controls, Lack of or inadequate procedures

  • 21 CFR 820.184Mar 12, 2025

    Lack of or inadequate DHR procedures

  • 21 CFR 820.198(a)Mar 12, 2025

    Complaints

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.