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883317

Adare Pharmaceuticals Srl — FEI 1000573478

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 30, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pessano Con Bornago (Italy)

Facility

Other inspections at this facility

  • 1204801 (VAI Fri Oct 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098299 (VAI Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006241 (VAI Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793805 (NAI Thu Jul 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 622477 (VAI Fri Oct 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
360321 CFR 211.160(b)Scientifically sound laboratory controls