FDA Inspection 1043181 — Department of Veterans Affairs Medical Center

Department of Veterans Affairs Medical Center — FEI 1172343

The FDA completed an inspection of Department of Veterans Affairs Medical Center on March 5, 2018 in Washington, DC. 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
March 5, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Washington, DC (United States)

Citations

IDCFRDescription
4621 CFR 606.40(a)(6)Provide space for quarantine of unsuitable for use items
6321 CFR 606.65Safe, sanitary, orderly storage
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs