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838415

Biolife, LLC — FEI 3003395204

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 28, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Sarasota, FL (United States)

Facility

Other inspections at this facility

  • 1097262 (NAI Wed May 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015370 (VAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 764655 (OAI Thu Jan 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 677473 (VAI Fri Aug 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 599890 (VAI Fri Jul 31 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events