FDA Inspection 1162184 — Blood Assurance, Inc.

Blood Assurance, Inc. — FEI 3012052149

The FDA completed an inspection of Blood Assurance, Inc. on February 14, 2022 in Columbia, 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
February 14, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Columbia, TN (United States)

Citations

IDCFRDescription
1503021 CFR 606.60(b)Equipment calibration frequency