1018119

Magnatone Hearing Aid Corp — FEI 1044692

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 14, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Casselberry, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
53721 CFR 820.70(a)Production processes
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events