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1078304

Poiesis Medical, LLC — FEI 3009425008

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Jupiter, FL (United States)

Facility

Other inspections at this facility

  • 1254008 (VAI Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063199 (VAI Thu Aug 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012583 (VAI Mon May 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818543 (NAI Tue Feb 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation