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995541

Grifols Bio Supplies Inc — FEI 3000719222

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2016
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1249252 (NAI Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113066 (NAI Fri Nov 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920015 (VAI Fri Feb 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 825221 (VAI Tue Mar 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 778187 (NAI Wed Apr 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1804121 CFR 606.160(e)(2)Cumulative deferral record HTLV, Chagas
1804421 CFR 610.40(a)(2)Test for HTLV, syphilis, West Nile, Chagas
1808221 CFR 630.10(e)(2)Additional Medical Assessment Factors
1809321 CFR 630.10(g)(1)Proof Of Identity
1809621 CFR 630.10(g)(2)(ii)Donor's Acknowledgment - Exculpatory language