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955350

ACS Dobfar S.p.A. — FEI 3006028606

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 19, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Teramo, San Nicolo A Tordino (Italy)

Facility

Other inspections at this facility

  • 1203381 (VAI Fri Apr 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123735 (VAI Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019162 (VAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881223 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777346 (VAI Tue Mar 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
126321 CFR 211.68(b)Computer control of master formula records
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
180921 CFR 211.160(a)Following/documenting laboratory controls
197521 CFR 211.182Written records kept in individual logs
200821 CFR 211.186(a)Written procedures followed
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
240221 CFR 211.194(a)(5)Testing Calculations
356521 CFR 211.58Buildings not maintained in good state of repair
440321 CFR 211.194(b)Test method modification records do not include