FDA 483 - Continental Dental Ceramics Inc. - July 15, 2022

An FDA inspection of Continental Dental Ceramics Inc. in Torrance, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for controlling nonconforming products, including documentation and review of rework activities. Additionally, process control procedures were not properly established, as manufacturing work tickets lacked necessary review and signatures.