FDA Inspection 813296 — Children's Hospital and Research Center at Oakland

Children's Hospital and Research Center at Oakland — FEI 2971437

The FDA completed an inspection of Children's Hospital and Research Center at Oakland on January 9, 2013 in Oakland, CA. 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
January 9, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Oakland, CA (United States)

Citations

IDCFRDescription
1503021 CFR 606.60(b)Equipment calibration frequency
5721 CFR 606.60(a)Maintain and clean equipment