FDA 483 - Ceragroup Industries Inc - October 11, 2022

Ceragroup Industries Inc, a medical device manufacturer of dental porcelain powders and pastes in Fort Lauderdale, FL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, equipment calibration, management review procedures, and supplier evaluation. These issues indicate a lack of adequate control over critical manufacturing processes and quality management.