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824106

Wright Medical Technology Inc — FEI 1043534

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 21, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Arlington, TN (United States)

Facility

Other inspections at this facility

  • 1250121 (NAI Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153158 (VAI Wed Sep 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102019 (NAI Thu Aug 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010322 (NAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 972995 (NAI Mon Jun 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233221 CFR 1271.170(b)Qualifications lacking
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1235621 CFR 1271.195(a)Adequate control, proper conditions
1239921 CFR 1271.230(a)Process validation procedures
1241421 CFR 1271.260(d)Corrective actions
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained