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588275

Walter L. Shepeard Community Blood Center, Inc. — FEI 1046616

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 15, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Augusta, GA (United States)

Facility

Other inspections at this facility

  • 1269616 (NAI Thu Jun 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179488 (NAI Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097500 (NAI Wed Jul 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020494 (NAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909673 (VAI Fri Jan 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
3121 CFR 606.20(b)Qualifications of responsible personnel
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations