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652147

Circulatory Technology Inc. — FEI 1000522036

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 15, 2010
Fiscal Year
2010
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))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
319021 CFR 820.30(g)Design validation acceptance criteria
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
418921 CFR 820.198(a)General
419321 CFR 806.10(b)Time to report - 10 days
63021 CFR 803.17Lack of Written MDR Procedures