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1214374

Coupler LLC — FEI 3003734940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Chester, PA (United States)

Facility

Other inspections at this facility

  • 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))
  • 1049813 (OAI Fri Apr 27 2018 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
163621 CFR 211.130(e)Packaging line inspection before use
359721 CFR 211.122(g)(3)Visual inspection
362921 CFR 211.170(b)Reserve samples identified, representative, stored
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages