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684642

Organ Procurement Agency of Michigan — FEI 3000718322

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 5, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Ann Arbor, MI (United States)

Facility

Other inspections at this facility

  • 1154387 (NAI Tue Sep 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111270 (NAI Wed Oct 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028519 (NAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920737 (NAI Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812240 (NAI Thu Dec 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1242221 CFR 1271.265(b)Shipment of HCT/Ps - pre-established criteria
1243721 CFR 1271.270(a)Records incomplete
1243821 CFR 1271.270(b)Management system re: core CGTPs
1501921 CFR 1271.160(d)Computer software verification