1147606

SpringCreek Fertility — FEI 3011408185

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 2, 2021
Fiscal Year
2021
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Centerville, OH (United States)

Citations

IDCFRDescription
1222221 CFR 1271.47(a)Design of procedures to ensure compliance
1222921 CFR 1271.50(a)Determination based on screening and testing
1223921 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely