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1152295

Amsino Healthcare (USA) Inc — FEI 1417519

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 20, 2021
Fiscal Year
2021
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))
  • 1017381 (OAI Mon Jul 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 902429 (VAI Wed Nov 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
122421 CFR 211.67(b)(6)Cleaning SOP/inspection
145121 CFR 211.113(b)Procedures for sterile drug products
197621 CFR 211.182Specific information required in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
313021 CFR 820.100(a)Lack of or inadequate procedures
366521 CFR 820.20(b)(3)Management representative
369621 CFR 820.100(b)Documentation
54621 CFR 820.75(a)Lack of or inadequate process validation