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951583

Alfasigma S.p.A. — FEI 3002808171

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pomezia (Italy)

Facility

Other inspections at this facility

  • 1293602 (VAI Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202245 (VAI Fri May 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056604 (VAI Thu Jun 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748680 (VAI Fri Sep 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145021 CFR 211.113(a)Procedures for non-sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs