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788465

Saint Lukes Memorial Hospital, Inc. — FEI 1000526693

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 28, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Ponce, PR (United States)

Facility

Other inspections at this facility

  • 1020841 (NAI Mon Jul 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933503 (NAI Thu Jul 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866263 (NAI Fri Feb 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 659338 (VAI Tue May 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations