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1120463

Coupler LLC — FEI 3003734940

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 10, 2020
Fiscal Year
2020
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))
  • 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
163621 CFR 211.130(e)Packaging line inspection before use
202721 CFR 211.192Investigations of discrepancies, failures