772546

Emory University Orthopaedics and Spine Hospital — FEI 3007202154

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 7, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Tucker, GA (United States)

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1244721 CFR 1271.290(b)Establishing a system
1244821 CFR 1271.290(c)Identification code
1245121 CFR 1271.290(c)Relating new code to old code