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952513

Catalent Anagni SRL — FEI 3002806546

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2015
Fiscal Year
2016
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Anagni (Italy)

Facility

Other inspections at this facility

  • 1278284 (VAI Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172076 (VAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063186 (VAI Fri Mar 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841312 (VAI Tue Jul 02 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779280 (VAI Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
354721 CFR 211.46(b)Equipment for Environmental Control
356521 CFR 211.58Buildings not maintained in good state of repair
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified