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1056562

Pharmaloz Manufacturing Inc. — FEI 2523447

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lebanon, PA (United States)

Facility

Other inspections at this facility

  • 1266720 (VAI Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215503 (NAI Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879146 (VAI Fri May 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 706645 (NAI Thu Jan 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
202821 CFR 211.192Extent of discrepancy, failure investigations
240121 CFR 211.194(a)(4)Complete Test Data
358121 CFR 211.101(d)Verification of component addition
434221 CFR 211.142(b)Storage under appropriate conditions
440921 CFR 211.194(a)(4)Data secured in course of each test