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827465

Taro Pharmaceuticals U.S.A., Inc. — FEI 2435212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 18, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hawthorne, NY (United States)

Facility

Other inspections at this facility

  • 1066575 (NAI Mon Aug 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907479 (VAI Fri Dec 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769594 (VAI Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 592198 (VAI Fri May 29 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
241921 CFR 211.198(a)Complaint Handling Procedure
673021 CFR 314.80(b)Failure to develop written procedures
682321 CFR 314.80(c)Failure by applicant to report ADE