FDA Inspection 1015126 — Department Of Defense - Navy (U.S. Naval Hospital Sigonella)

Department Of Defense - Navy (U.S. Naval Hospital Sigonella) — FEI 3002808608

The FDA completed an inspection of Department Of Defense - Navy (U.S. Naval Hospital Sigonella) on May 10, 2017 in Sigonella. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
May 10, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Sigonella (Italy)

Citations

IDCFRDescription
11321 CFR 606.121(b)Collection/initial processing facility labels
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

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