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1081078

Northwestern Medicine Central DuPage Hospital — FEI 1000159973

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 22, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Winfield, IL (United States)

Facility

Other inspections at this facility

  • 1246188 (NAI Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122292 (NAI Tue Feb 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985177 (NAI Tue Dec 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 610717 (NAI Mon Aug 24 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1228821 CFR 1271.80(c)Manufacturer instructions not followed
1231021 CFR 1271.160(a)All core requirements covered in program
1232421 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1237121 CFR 1271.200(a)Cleaned, sanitized per established schedules
1244321 CFR 1271.270(d)Retention time (10 year rules)