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592198

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 29, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Hawthorne, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

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))
  • 827465 (VAI Thu Apr 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769594 (VAI Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
672821 CFR 314.80(b)Failure to review ADE information
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports