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1055374

Advanced Accelerator Applications (Italy) S.r.l. — FEI 3009551251

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 8, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saluggia (Italy)

Facility

Other inspections at this facility

  • 1275316 (VAI Fri Mar 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1128755 (VAI Fri Oct 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948416 (VAI Tue Oct 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
126321 CFR 211.68(b)Computer control of master formula records
138821 CFR 211.101(d)Component addition checked by 2nd person
145121 CFR 211.113(b)Procedures for sterile drug products
191221 CFR 211.166(a)Written program not followed
203121 CFR 211.194(a)Complete test data included in records
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
440421 CFR 211.194(a)(1)Sample identification and other information
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications