FDA Inspection 646414 — Danville Regional Medical Center/Blood Bank

Danville Regional Medical Center/Blood Bank — FEI 1171317

The FDA completed an inspection of Danville Regional Medical Center/Blood Bank on January 22, 2010 in Danville, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 22, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Danville, VA (United States)

Citations

IDCFRDescription
22421 CFR 640.4(f)Arm preparation
4121 CFR 606.40(a)(1)Provide space for examination
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs