FDA Inspection 1085960 — C.A.R.E. Fertility

C.A.R.E. Fertility — FEI 3007390777

The FDA completed an inspection of C.A.R.E. Fertility on April 11, 2019 in Glendale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Glendale, CA (United States)

Citations

IDCFRDescription
1228221 CFR 1271.75(d)Donors with risks not determined ineligible