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862365

Eurofins Donor & Product Testing LLC — FEI 1000477683

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 14, 2014
Fiscal Year
2014
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))
  • 980778 (VAI Fri Feb 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1228821 CFR 1271.80(c)Manufacturer instructions not followed
1232021 CFR 1271.160(b)(3)Actions verified, short and long term solutions
1233621 CFR 1271.180(a)Procedures to meet core CTGP