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1218958

Dercher Enterprises, Inc., DBA Gordon Laboratories — FEI 2510734

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 20, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Upper Darby, PA (United States)

Facility

Other inspections at this facility

  • 1173149 (OAI Mon Jun 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1142151 (OAI Tue May 04 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999631 (VAI Thu Jan 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 815018 (VAI Fri Jan 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 559323 (VAI Thu Dec 18 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
192021 CFR 211.166(a)(3)Valid stability test methods
201121 CFR 211.188(a)Accurate reproduction
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
434221 CFR 211.142(b)Storage under appropriate conditions
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages