FDA Inspection 907102 — UNC Healthcare/Fertility

UNC Healthcare/Fertility — FEI 3005070676

The FDA completed an inspection of UNC Healthcare/Fertility on Dec 16, 2014 in Raleigh, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 16, 2014
Fiscal Year
2015
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Raleigh, NC (United States)

Citations

IDCFRDescription
1249021 CFR 1271.85(b)(1)Cell-associated CD