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1100977

Biomerieux Inc — FEI 1950204

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 20, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Hazelwood, MO (United States)

Facility

Other inspections at this facility

  • 1000732 (VAI Wed Jan 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929513 (VAI Tue Jun 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891090 (OAI Wed Jul 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 817590 (VAI Tue Feb 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752880 (NAI Mon Nov 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
73221 CFR 803.50(a)(2)Individual Report of Malfunction