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1230375

Actavis Laboratories UT, Inc. — FEI 1000117147

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 19, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1282698 (VAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149636 (VAI Fri Aug 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065736 (NAI Thu Aug 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035181 (NAI Wed Oct 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953640 (NAI Tue Dec 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145021 CFR 211.113(a)Procedures for non-sterile drug products
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
430321 CFR 211.67(b)Written procedures fail to include