FDA Inspection 590673 — Stem Cell Cryo Bank, LLC

Stem Cell Cryo Bank, LLC — FEI 3004355298

The FDA completed an inspection of Stem Cell Cryo Bank, LLC on June 18, 2009 in Deerfield Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Deerfield Beach, FL (United States)

Citations

IDCFRDescription
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1243721 CFR 1271.270(a)Records incomplete