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1017863

LEESAR, INC — FEI 3010166880

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 12, 2017
Fiscal Year
2017
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))
  • 1155647 (VAI Fri Oct 29 2021 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
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
202721 CFR 211.192Investigations of discrepancies, failures