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1001126

McPherson Enterprises, Inc., dba Implantable Devices — FEI 1033972

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 9, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Pinellas Park, FL (United States)

Facility

Other inspections at this facility

  • 1217039 (NAI Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155922 (VAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805236 (VAI Mon Oct 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 579548 (VAI Tue May 05 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
319021 CFR 820.30(g)Design validation acceptance criteria
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
54621 CFR 820.75(a)Lack of or inadequate process validation