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997579

American Regent Inc. — FEI 3005761472

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 7, 2016
Fiscal Year
2017
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))
  • 1083384 (VAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024378 (NAI Fri Aug 18 2017 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
356521 CFR 211.58Buildings not maintained in good state of repair