872990

Repromed Fertility Center — FEI 3008545334

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 2, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Dallas, TX (United States)

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1222321 CFR 1271.47(b)Review and approval of procedures
1222921 CFR 1271.50(a)Determination based on screening and testing
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely