632319

Wake Forest Baptist Health- Blood Bank Hospital — FEI 1071670

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 19, 2009
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Winston Salem, NC (United States)

Citations

IDCFRDescription
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events
64221 CFR 803.18(b)(1)(i)Adverse events--all info not in file
65621 CFR 803.30(a)(1)Report of Death Within 10 Days