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999631

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 19, 2017
Fiscal Year
2017
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))
  • 1142151 (OAI Tue May 04 2021 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
136121 CFR 211.100(a)Absence of Written Procedures
141121 CFR 211.105(b)Distinctive ID or code not recorded in batch record
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
192621 CFR 211.166(b)Adequate number of batches on stability
430621 CFR 211.80(a)Written Procedures Not Followed