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1142151

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

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 4, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Upper Darby, PA (United States)

Facility

Other inspections at this facility

  • 1218958 (OAI Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1173149 (OAI Mon Jun 13 2022 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
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
356721 CFR 211.84(d)(2)Component identification test
430321 CFR 211.67(b)Written procedures fail to include