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1269588

LEESAR, INC — FEI 3010166880

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 9, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Myers, FL (United States)

Facility

Other inspections at this facility

  • 1276435 (NAI Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155647 (VAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017863 (OAI Wed Jul 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 893985 (VAI Fri Aug 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures