FDA Inspection 572494 — M Health Fairview University Of Minnesota Medical Center, East Bank-Blood Bank

M Health Fairview University Of Minnesota Medical Center, East Bank-Blood Bank — FEI 2170604

The FDA completed an inspection of M Health Fairview University Of Minnesota Medical Center, East Bank-Blood Bank on Mar 30, 2009 in Minneapolis, MN. 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
Mar 30, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Minneapolis, MN (United States)

Citations

IDCFRDescription
15921 CFR 606.160(a)(1)Legibility and indelibility
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs