1040654

Foulk Nevada Fertility Center, PC — FEI 3005339958

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 1, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Las Vegas, NV (United States)

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1223021 CFR 1271.50(a)Responsible person to determine, document
1223121 CFR 1271.50(b)(1)Donor screening standards
1223521 CFR 1271.55(a)(1)Personal information included in I.D. code
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1225721 CFR 1271.60(c)(2)Records stating determination not completed
1225821 CFR 1271.60(c)(3)Statement of restrictions
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1249321 CFR 1271.90(c)Eligibility not required--warning labels