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848609

Lucero Medical LLC — FEI 3008775608

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 12, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Richfield, OH (United States)

Facility

Other inspections at this facility

  • 1178977 (VAI Wed Sep 07 2022 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
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
1471821 CFR 820.30(g)Design validation - Risk analysis
255721 CFR 820.30(c)Design input - documentation
319121 CFR 820.30(g)Design validation - production units
342721 CFR 820.50(a)(2)Supplier oversight