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996793

Klockner Of North America — FEI 3011395139

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 28, 2016
Fiscal Year
2017
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1247485 (NAI Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081204 (VAI Wed Feb 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802887 (VAI Wed Oct 03 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1243321 CFR 1271.265(f)Return to inventory--procedures
1245721 CFR 1271.320(a)Procedures re complaints