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1083384

American Regent Inc. — FEI 3005761472

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hilliard, OH (United States)

Facility

Other inspections at this facility

  • 1210501 (VAI Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024378 (NAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997579 (VAI Wed Dec 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872295 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 745670 (NAI Fri Sep 30 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications