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646312

Lannett Company, Inc. — FEI 2510865

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 9, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1167830 (NAI Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081137 (NAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018610 (NAI Thu Jun 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987590 (VAI Fri Sep 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844132 (NAI Tue Aug 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
139621 CFR 211.42(c)(2)Rejected Material Area
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
358521 CFR 211.110(a)Control procedures to monitor and validate performance
363921 CFR 211.204Returned drug procedures in writing and followed
364121 CFR 211.204Record information inclusions
441721 CFR 211.204Associated batches implicated, investigated