FDA 483 - BioTissue Holdings Inc - March 06, 2024

BioTissue Holdings Inc, a medical device manufacturer in Miami, FL, was cited with four observations on a Form 483. The inspection revealed significant failures in submitting Medical Device Reports (MDRs) for serious injuries and device malfunctions, inadequate evaluation of device complaints, and insufficient documentation of corrective and preventive actions. These issues indicate deficiencies in the firm's quality system regarding post-market surveillance and quality control.