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1155922

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2021
Fiscal Year
2022
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))
  • 1001126 (NAI Thu Feb 09 2017 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
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures