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1218928

Iridex Corporation — FEI 2939653

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 20, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Mountain View, CA (United States)

Facility

Other inspections at this facility

  • 988542 (NAI Fri Aug 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906286 (VAI Tue Dec 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836353 (VAI Wed Jul 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 714014 (VAI Thu Mar 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
74021 CFR 803.52(a)(3)Patient Gender
77421 CFR 803.52(e)(4)Date Received by Manufacturer