FDA Inspection 1115271 — Blood Assurance Inc.

Blood Assurance Inc. — FEI 3002660779

The FDA completed an inspection of Blood Assurance Inc. on January 17, 2020 in Hixson, TN. 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
January 17, 2020
Fiscal Year
2020
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Hixson, TN (United States)

Citations

IDCFRDescription
4121 CFR 606.40(a)(1)Provide space for examination