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1230374

LGM Pharma Solutions, LLC — FEI 3017140477

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 1, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1232056 (NAI Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120565 (NAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062404 (VAI Fri Aug 17 2018 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
360221 CFR 211.160(a)Deviations from laboratory control requirements