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920580

Teva Puerto Rico LLC — FEI 2619635

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fajardo, PR (United States)

Facility

Other inspections at this facility

  • 1193314 (VAI Wed Nov 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064456 (NAI Fri Aug 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010797 (NAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826944 (VAI Thu Apr 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800308 (NAI Thu Sep 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications