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778886

Innovasis, Inc — FEI 3004719693

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 27, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1102677 (NAI Tue Aug 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979759 (NAI Wed Jun 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879760 (NAI Thu May 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 594578 (VAI Fri Jun 26 2009 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
1245421 CFR 1271.290(f)Timely informing of consignees
1471821 CFR 820.30(g)Design validation - Risk analysis
313021 CFR 820.100(a)Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation