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1111775

Circulatory Technology Inc. — FEI 1000522036

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 4, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Oyster Bay, NY (United States)

Facility

Other inspections at this facility

  • 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))
  • 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
1471821 CFR 820.30(g)Design validation - Risk analysis
310421 CFR 820.30(j)Design history file
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
44721 CFR 820.40Lack of procedures, or not maintained
73221 CFR 803.50(a)(2)Individual Report of Malfunction