1021059

Fertility Technology Resources, Inc. — FEI 3003889409

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Murphy, NC (United States)

Citations

IDCFRDescription
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
342621 CFR 820.50(a)(1)Documented evaluation
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
405921 CFR 820.22Quality Audits - defined intervals