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805706

Lannett Company Inc. — FEI 1819171

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 31, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Seymour, IN (United States)

Facility

Other inspections at this facility

  • 1187299 (VAI Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060761 (VAI Mon Jul 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040079 (VAI Fri Feb 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907339 (VAI Tue Dec 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844613 (VAI Thu Aug 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
202821 CFR 211.192Extent of discrepancy, failure investigations
241921 CFR 211.198(a)Complaint Handling Procedure
361621 CFR 211.165(d)Acceptance criteria for sampling & testing