FDA Inspection 847540 — Department Of Defense - Navy

Department Of Defense - Navy — FEI 1176560

The FDA completed an inspection of Department Of Defense - Navy on Sep 9, 2013 in Bethesda, MD. 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)
End Date
Sep 9, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bethesda, MD (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
922521 CFR 606.171Biological product deviation report