FDA Inspection 1096374 — Creative Testing Solutions

Creative Testing Solutions — FEI 1000140241

The FDA completed an inspection of Creative Testing Solutions on July 16, 2019 in Charlotte, NC. 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
July 16, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
926221 CFR 610.40(b)One or more approved screening tests