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927426

ImpactLife — FEI 1970356

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 21, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Davenport, IA (United States)

Facility

Other inspections at this facility

  • 1261653 (NAI Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107342 (NAI Thu Oct 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017401 (NAI Mon Jun 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977294 (NAI Thu Jun 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937275 (NAI Tue Aug 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations