FDA 483 - BioSculptor Corporation - March 13, 2020

BioSculptor Corporation, a medical device manufacturer in Hialeah, FL, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality system procedures related to production process control, complaint handling, incoming product acceptance, labeling, equipment calibration, and internal quality audits. These issues indicate a systemic lack of control over critical manufacturing and quality assurance activities.