FDA Inspection 1246462 — Carolinas Medical Center Blood bank

Carolinas Medical Center Blood bank — FEI 1072484

The FDA completed an inspection of Carolinas Medical Center Blood bank on August 7, 2024 in Charlotte, NC. 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
August 7, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
15021 CFR 606.151(e)Procedures to maintain records of emergency transfusions