inforMED
FEI 1000126037

Ameritekusa, Inc.

125 130th St SE Ste 200, EVERETT, WA, US

MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device

Registered product codes

1 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 1000126037.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Jul 10, 2024

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Jul 10, 2024

    Postmarket Assurance: Devices · Citations posted

Inspection citations

2 on file

  • 21 CFR 820.50Jul 10, 2024

    Purchasing controls, Lack of or inadequate procedures

  • 21 CFR 820.250(b)Jul 10, 2024

    Sampling methods - 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.