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1062404

LGM Pharma Solutions, LLC — FEI 3017140477

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Irvine, CA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1232056 (NAI Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230374 (VAI Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120565 (NAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006282 (NAI Mon Feb 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007414 (VAI Tue Dec 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1803321 CFR 314.80(g)(1)Failure to submit electronic format safety report
673021 CFR 314.80(b)Failure to develop written procedures
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
891221 CFR 314.81(b)(2)Timely submission