FDA Inspection 643528 — VACT Healthcare System

VACT Healthcare System — FEI 1271446

The FDA completed an inspection of VACT Healthcare System on February 3, 2010 in West Haven, CT. 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 3, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
West Haven, CT (United States)

Citations

IDCFRDescription
9821 CFR 606.100(c)Thorough investigations