FDA 483 - B & D Dental Corporation - August 16, 2022

B & D Dental Corporation received a Form 483 with ten observations related to significant deficiencies in their quality system. The inspection revealed issues across multiple areas including process validation, acceptance activities, equipment calibration, device history records, CAPA, complaint handling, nonconforming product control, purchasing, training, and document change control. These findings indicate a need for comprehensive improvements to ensure product quality and regulatory compliance.