895007

Florida Institute for Reproductive Sciences and Technologies — FEI 3004516706

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 9, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Weston, FL (United States)

Citations

IDCFRDescription
1222321 CFR 1271.47(b)Review and approval of procedures
1224221 CFR 1271.55(c)Name and personal info on accompanying records
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227821 CFR 1271.75(a)(2)Risks associated with xenotransplantation