912469

Wright Medical Technology, Inc. - District Service Center - St. Louis — FEI 3005956797

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 4, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Fenton, MO (United States)

Citations

IDCFRDescription
1232221 CFR 1271.160(b)(4)Training of personnel
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1233921 CFR 1271.180(c)Availability of procedures
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1245221 CFR 1271.290(d)Recording I.D. code and type of HCT/P