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980778

Eurofins Donor & Product Testing LLC — FEI 1000477683

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 19, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
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))
  • 1090119 (NAI Fri May 17 2019 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))
  • 880425 (NAI Fri Apr 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1228821 CFR 1271.80(c)Manufacturer instructions not followed
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1234221 CFR 1271.190(a)Size, construction, location--prevent mix-ups etc.
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1236221 CFR 1271.195(b)Corrective actions
1236921 CFR 1271.200(b)Procedures inadequate
1237021 CFR 1271.200(c)Calibration procedures and schedules (general)
1239521 CFR 1271.225Verification/validation
1239821 CFR 1271.230(a)Validation & approval--established procedures
1243721 CFR 1271.270(a)Records incomplete