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1149378

Teva Parenteral Medicines, Inc. — FEI 2027158

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 20, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1100853 (VAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997582 (NAI Mon Dec 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980903 (VAI Fri Jul 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882240 (NAI Fri Jun 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834806 (VAI Tue Jun 04 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
125621 CFR 211.68(b)Backup file not maintained
136121 CFR 211.100(a)Absence of Written Procedures
143121 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
1785521 CFR 212.60(e)Equipment
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance