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1304322

BioTissue Holdings Inc — FEI 3009809074

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 18, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Doral, FL (United States)

Facility

Other inspections at this facility

  • 1230477 (VAI Wed Mar 06 2024 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
23213ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
23255ISO 13485:2016 Clause 8.5.2Corrective action not taken
73121 CFR 803.50(a)(1)Report of Death or Serious Injury