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736833

Teva Puerto Rico LLC — FEI 2619635

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 29, 2011
Fiscal Year
2011
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))
  • 920580 (VAI Fri Mar 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826944 (VAI Thu Apr 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.