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1167402

SSM-SLUH, Inc. — FEI 1972831

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 19, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Saint Louis, MO (United States)

Facility

Other inspections at this facility

  • 1293580 (NAI Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1197718 (VAI Fri Feb 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1058150 (NAI Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977256 (NAI Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879591 (NAI Thu May 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15021 CFR 606.151(e)Procedures to maintain records of emergency transfusions
430421 CFR 211.68(b)Written record not kept of program and validation data
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs