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1067277

Circulatory Technology Inc. — FEI 1000522036

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 26, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 976745 (VAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936945 (VAI Fri Jul 31 2015 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
243021 CFR 820.30(b)Design plans - Lack of or inadequate
310421 CFR 820.30(j)Design history file
317221 CFR 820.198(c)Investigation of device failures
326621 CFR 820.86Acceptance status
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
369621 CFR 820.100(b)Documentation
407021 CFR 820.30(g)Design validation - documentation
73221 CFR 803.50(a)(2)Individual Report of Malfunction