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1049813

Coupler LLC — FEI 3003734940

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 27, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Chester, PA (United States)

Facility

Other inspections at this facility

  • 1214374 (VAI Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148607 (OAI Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120463 (OAI Tue Mar 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833469 (VAI Wed May 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
191421 CFR 211.166(a)Lack of written stability program
357021 CFR 211.100(a)Approval and review of procedures
900121 CFR 211.22(a)Lack of quality control unit