inforMED
FEI 1000120916

Precision Optics Corp.

22 E Broadway, GARDNER, MA, US

MDR events0All time
Recalls0All time
Registered products9
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)

Registered product codes

9 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 1000120916.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Sep 11, 2025

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Sep 11, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

6 on file

  • 21 CFR 820.50Sep 11, 2025

    Purchasing controls, Lack of or inadequate procedures

  • 21 CFR 820.60Sep 11, 2025

    Identification procedures, Lack of or inadequate procedures

  • 21 CFR 820.90(a)Sep 11, 2025

    Nonconforming product, Lack of or inadequate procedures

  • 21 CFR 820.100(a)Sep 11, 2025

    Lack of or inadequate procedures

  • 21 CFR 820.184Sep 11, 2025

    DHR content

  • 21 CFR 820.198(a)Sep 11, 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.