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1192164

Cenexi Laboratoires Thissen SA — FEI 3007388138

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Braine-L'Alleud (Belgium)

Facility

Other inspections at this facility

  • 1250906 (VAI Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141824 (VAI Wed Feb 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002425 (VAI Fri Dec 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934545 (VAI Thu Jun 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878521 (NAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
113621 CFR 211.25(c)Inadequate number of personnel
145121 CFR 211.113(b)Procedures for sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
189121 CFR 211.165(f)Failing drug products not rejected
356521 CFR 211.58Buildings not maintained in good state of repair