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1267356

Catalent Greenville Inc — FEI 3000209735

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Greenville, NC (United States)

Facility

Other inspections at this facility

  • 1231042 (NAI Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097051 (VAI Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065149 (NAI Fri Aug 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019260 (NAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983236 (NAI Thu Jul 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
188521 CFR 211.165(b)Microbiological testing
191221 CFR 211.166(a)Written program not followed