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1080109

Catalent Pharma Solutions, LLC — FEI 1811396

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 22, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Petersburg, FL (United States)

Facility

Other inspections at this facility

  • 1282788 (VAI Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229815 (NAI Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229344 (NAI Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210540 (VAI Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1101180 (VAI Wed Aug 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
191221 CFR 211.166(a)Written program not followed
360321 CFR 211.160(b)Scientifically sound laboratory controls