inforMED
FEI 3000190675

Sota Precision Optics, Inc.

1073 N Batavia St Ste B, ORANGE, CA, US

MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device

Registered product codes

4 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 3000190675.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Aug 15, 2025

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Aug 15, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

3 on file

  • 21 CFR 820.100(a)Aug 15, 2025

    Lack of or inadequate procedures

  • 21 CFR 820.80(d)Aug 15, 2025

    Lack of or inadequate final acceptance procedures

  • 21 CFR 820.198(a)Aug 15, 2025

    Lack of or inadequate complaint 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.