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1286122

Biogenex Laboratories, Inc. — FEI 2936532

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 6, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Fremont, CA (United States)

Facility

Other inspections at this facility

  • 933666 (NAI Thu Jul 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886073 (VAI Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 762651 (NAI Thu Jan 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760537 (VAI Fri Jan 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
2279521 CFR 801.20(a)Label to bear a unique device identifier
73221 CFR 803.50(a)(2)Individual Report of Malfunction