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1056856

Catalent Pharma Solutions, LLC — FEI 1811396

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2018
Fiscal Year
2018
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
202621 CFR 211.192Quality control unit review of records
358321 CFR 211.110(a)Written in-process control procedures