FDA Inspection 908677 — Virginia Fertility Associates, LLC

Virginia Fertility Associates, LLC — FEI 3003939262

The FDA completed an inspection of Virginia Fertility Associates, LLC on December 19, 2014 in Richmond, VA. 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
December 19, 2014
Fiscal Year
2015
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Richmond, VA (United States)

Citations

IDCFRDescription
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled