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1266720

Pharmaloz Manufacturing Inc. — FEI 2523447

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 14, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lebanon, PA (United States)

Facility

Other inspections at this facility

  • 1215503 (NAI Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056562 (VAI Thu Jun 21 2018 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
202821 CFR 211.192Extent of discrepancy, failure investigations
434221 CFR 211.142(b)Storage under appropriate conditions