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1152920

Lusys Laboratories, Inc. — FEI 3004473533

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 24, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1078904 (VAI Thu Feb 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053624 (VAI Mon May 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913393 (OAI Thu Feb 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819228 (NAI Thu Feb 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
369921 CFR 820.160(b)Distribution records
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation