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755587

Banco de Sangre ASEM — FEI 3006710143

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 29, 2011
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
San Juan, PR (United States)

Facility

Other inspections at this facility

  • 1284576 (NAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1207803 (NAI Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092776 (VAI Wed Jun 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015511 (VAI Thu Jun 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924006 (VAI Wed Apr 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
924321 CFR 630.40(a)Notification
9821 CFR 606.100(c)Thorough investigations