inforMED
FEI 2410808

Electronic Development Labs, Inc.

244 OAKLAND DR., DANVILLE, VA, 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 2410808.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Aug 8, 2024

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Aug 8, 2024

    Postmarket Assurance: Devices · Citations posted

Inspection citations

4 on file

  • 21 CFR 820.22Aug 8, 2024

    Quality audits - Lack of or inadequate procedures

  • 21 CFR 820.30(g)Aug 8, 2024

    Design validation- Lack of or inadequate procedures

  • 21 CFR 820.30(i)Aug 8, 2024

    Design changes - Lack of or Inadequate Procedures

  • 21 CFR 820.184Aug 8, 2024

    Lack of or inadequate DHR 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.