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1050315

Sterigenics U.S. LLC — FEI 1000114185

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 27, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Mulberry, FL (United States)

Facility

Other inspections at this facility

  • 1243518 (VAI Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953954 (NAI Tue Jan 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821396 (NAI Wed Mar 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773959 (NAI Mon Mar 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733440 (NAI Mon Jul 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
54621 CFR 820.75(a)Lack of or inadequate process validation