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1090119

Eurofins Donor & Product Testing LLC — FEI 1000477683

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 17, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Centennial, CO (United States)

Facility

Other inspections at this facility

  • 1245237 (VAI Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073911 (NAI Thu Nov 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026048 (NAI Fri Jun 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980778 (VAI Fri Feb 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880425 (NAI Fri Apr 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1234321 CFR 1271.190(a)State of repair
1235121 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
1237021 CFR 1271.200(c)Calibration procedures and schedules (general)
1243721 CFR 1271.270(a)Records incomplete