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848405

Amsino Healthcare (USA) Inc — FEI 1417519

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Vernon Hills, IL (United States)

Facility

Other inspections at this facility

  • 1261291 (OAI Thu Jan 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1222628 (VAI Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1193127 (OAI Mon Dec 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152295 (VAI Mon Sep 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017381 (OAI Mon Jul 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
358521 CFR 211.110(a)Control procedures to monitor and validate performance
368221 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.