Home / Inspections / 1057004

1057004

Specialty Blood Center — FEI 3006384472

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Charleston, SC (United States)

Facility

Other inspections at this facility

  • 1246370 (VAI Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113320 (VAI Mon Dec 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942088 (VAI Wed Sep 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895297 (VAI Wed Sep 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 708410 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
11421 CFR 606.121(c)(1)Proper name of product
12321 CFR 606.121(c)(4)(i)Expiration date
1803821 CFR 606.100(b)SOPs for investigations, records
1804021 CFR 606.160(e)(2)Cumulative deferral record HIV, HBV, HCV
1806721 CFR 630.5(d)Emergency medical services
1808121 CFR 630.10(e)(1)Medical Assessment Factors
1808721 CFR 630.10(f)(3)(i)(B)Hemoglobin or Hematocrit for male allogeneic donor
1809321 CFR 630.10(g)(1)Proof Of Identity
1809421 CFR 630.10(g)(2)Donor's Acknowledgment
923521 CFR 630.40(c)Documentation