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1195585

Catalent Pharma Solutions LLC — FEI 1000110912

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Morrisville, NC (United States)

Facility

Other inspections at this facility

  • 1229061 (VAI Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131607 (OAI Mon Sep 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116748 (NAI Fri Dec 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081169 (NAI Mon Mar 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086471 (NAI Fri Feb 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
193321 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
361321 CFR 211.160(b)(4)Establishment of calibration procedures