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777346

ACS Dobfar S.p.A. — FEI 3006028606

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 27, 2012
Fiscal Year
2012
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))
  • 955350 (OAI Tue Jan 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881223 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
145121 CFR 211.113(b)Procedures for sterile drug products
203121 CFR 211.194(a)Complete test data included in records
354621 CFR 211.46(a)Adequate ventilation not provided
360321 CFR 211.160(b)Scientifically sound laboratory controls
440421 CFR 211.194(a)(1)Sample identification and other information