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727932

Presbyterian Hospital Blood Bank — FEI 1672761

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 29, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Albuquerque, NM (United States)

Facility

Other inspections at this facility

  • 1247869 (NAI Wed Jul 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079363 (NAI Wed Jan 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020801 (NAI Thu Mar 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916671 (NAI Wed Mar 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841949 (VAI Thu Jul 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
126121 CFR 211.68(a)Written calibration / inspection records not kept
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
904421 CFR 600.10(b)Personnel capabilities
9821 CFR 606.100(c)Thorough investigations