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921522

Sheffield Pharmaceuticals, LLC — FEI 1210513

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
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))
  • 776935 (VAI Fri Apr 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
180221 CFR 211.84(b)Representative Samples
202821 CFR 211.192Extent of discrepancy, failure investigations
369021 CFR 820.100(a)(3)Identification of actions needed
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
439121 CFR 211.180(e)(2)Items to cover on annual reviews