FDA 483 - BioTissue Holdings Inc - February 18, 2026

BioTissue Holdings Inc, a medical device manufacturer in Doral, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to submit Medical Device Reports for serious injuries related to its Prokera devices, despite multiple patient complaints involving pain, inflammation, and lacerations. Additionally, the company's risk management process did not adequately incorporate feedback regarding patient pain, and its corrective action system failed to initiate CAPAs for recurring complaints.