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1178163

Sterigenics US, LLC — FEI 3001236277

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 23, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Worth, TX (United States)

Facility

Other inspections at this facility

  • 1304404 (NAI Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1299194 (NAI Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215806 (VAI Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994267 (NAI Wed Dec 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953345 (NAI Fri Dec 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
360221 CFR 211.160(a)Deviations from laboratory control requirements
438921 CFR 211.198(a)Procedures to be written and followed