Home / Inspections / 936945

936945

Circulatory Technology Inc. — FEI 1000522036

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 31, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Oyster Bay, NY (United States)

Facility

Other inspections at this facility

  • 1111775 (VAI Wed Dec 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067277 (OAI Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976745 (VAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822890 (NAI Mon Mar 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723898 (NAI Mon Apr 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
237121 CFR 820.30(a)Design control - no procedures
263021 CFR 820.30(e)Design review - documentation
317221 CFR 820.198(c)Investigation of device failures
319021 CFR 820.30(g)Design validation acceptance criteria
369621 CFR 820.100(b)Documentation