FDA Inspection 1031065 — INOVA Health Care Services Blood Donor Services

INOVA Health Care Services Blood Donor Services — FEI 3005175634

The FDA completed an inspection of INOVA Health Care Services Blood Donor Services on November 9, 2017 in Annandale, VA. 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
November 9, 2017
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Annandale, VA (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs