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1230477

BioTissue Holdings Inc — FEI 3009809074

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Doral, FL (United States)

Facility

Other inspections at this facility

  • 1304322 (VAI Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1101487 (NAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096403 (VAI Tue Jul 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040962 (VAI Tue Feb 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948156 (NAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
369621 CFR 820.100(b)Documentation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury
73221 CFR 803.50(a)(2)Individual Report of Malfunction