FDA Inspection 665679 — Carris Health, LLC

Carris Health, LLC — FEI 2173910

The FDA completed an inspection of Carris Health, LLC on May 21, 2010 in Willmar, MN. 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) (VAI)
End Date
May 21, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Willmar, MN (United States)

Citations

IDCFRDescription
5721 CFR 606.60(a)Maintain and clean equipment
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration