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1272617

Ion Medical, Inc. — FEI 3006747129

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 13, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Jacksonville, FL (United States)

Facility

Other inspections at this facility

  • 1050613 (NAI Thu Mar 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895077 (NAI Mon Sep 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746941 (NAI Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
319921 CFR 820.40(a)Document review, approval documentation
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures