FDA 483 - BioTissue Holdings Inc - July 16, 2019

TissueTech, Inc. in Doral, FL, a medical device manufacturer, received a Form 483 with five observations during an inspection from July 8-16, 2019. The observations primarily concern inadequate procedures for process control, rework, corrective and preventive actions, document control, and medical device reporting. These issues indicate significant deficiencies in the firm's quality system management.