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908678

Haupt Pharma Latina Srl — FEI 3007687501

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 4, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Latina (Italy)

Facility

Other inspections at this facility

  • 1237210 (OAI Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206882 (VAI Fri Jul 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059418 (VAI Thu Jun 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004993 (VAI Fri Dec 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812047 (VAI Wed Dec 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
355721 CFR 211.52Washing and toilet facilities are deficient
356521 CFR 211.58Buildings not maintained in good state of repair