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1067491

Sheffield Pharmaceuticals, LLC — FEI 1210513

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 25, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New London, CT (United States)

Facility

Other inspections at this facility

  • 1234860 (VAI Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082940 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961086 (VAI Thu Feb 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921522 (VAI Thu Mar 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 776935 (VAI Fri Apr 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
438921 CFR 211.198(a)Procedures to be written and followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews