Home / Inspections / 1112331

1112331

Magnatone Hearing Aid Corp — FEI 1044692

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 10, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Casselberry, FL (United States)

Facility

Other inspections at this facility

  • 1275528 (VAI Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018119 (NAI Fri Jul 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974690 (VAI Mon Jun 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471421 CFR 820.30(c)Design input - Lack of or inadequate procedures
1471821 CFR 820.30(g)Design validation - Risk analysis
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures