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1155647

LEESAR, INC — FEI 3010166880

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2021
Fiscal Year
2022
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))
  • 1269588 (VAI Fri May 09 2025 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
202721 CFR 211.192Investigations of discrepancies, failures
21422FDCA 503B(b)(2)(A)Outsourcing facility, compounded drug report follow up
220321 CFR 211.186(b)(7)Theoretical Yield and Percentages
358321 CFR 211.110(a)Written in-process control procedures