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879597

Organogenesis, Inc. — FEI 1000148471

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 13, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Canton, MA (United States)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 1158368 (NAI Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055007 (VAI Fri Jun 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050416 (VAI Thu Apr 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014830 (NAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942390 (NAI Wed Sep 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
327021 CFR 820.80(c)Documentation
419321 CFR 806.10(b)Time to report - 10 days
73121 CFR 803.50(a)(1)Report of Death or Serious Injury