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985219

Lonza Bend Inc. — FEI 3003722743

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bend, OR (United States)

Facility

Other inspections at this facility

  • 1178398 (VAI Fri Aug 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018924 (VAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985217 (VAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
126321 CFR 211.68(b)Computer control of master formula records
186821 CFR 211.94(b)Protection from external factors
202821 CFR 211.192Extent of discrepancy, failure investigations
242021 CFR 211.198(a)Quality Control Review