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1234860

Sheffield Pharmaceuticals, LLC — FEI 1210513

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New London, CT (United States)

Facility

Other inspections at this facility

  • 1082940 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067491 (VAI Tue Sep 25 2018 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
202721 CFR 211.192Investigations of discrepancies, failures
2142521 CFR 820.184(f)DHR - UDI not included
310421 CFR 820.30(j)Design history file
356521 CFR 211.58Buildings not maintained in good state of repair
439121 CFR 211.180(e)(2)Items to cover on annual reviews