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1178977

Lucero Medical LLC — FEI 3008775608

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 7, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Richfield, OH (United States)

Facility

Other inspections at this facility

  • 848609 (NAI Thu Sep 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 788078 (VAI Fri Jun 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754485 (OAI Tue Nov 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
313221 CFR 820.120Lack of or inadequate procedures for labeling
341521 CFR 820.22Quality Audit/Reaudit - conducted
342721 CFR 820.50(a)(2)Supplier oversight
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate