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776935

Sheffield Pharmaceuticals, LLC — FEI 1210513

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 13, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
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))
  • 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))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
438721 CFR 211.198(a)Reporting of adverse drug experience to FDA
439021 CFR 211.180(c)Photocopying of records not allowed