FDA 483 - Seattle Bioceramics, Inc. - July 01, 2024

An FDA inspection of Seattle Bioceramics, Inc., a manufacturer of Pürzir Dental Zirconia devices, was conducted from June 24 to July 1, 2024, resulting in a Form FDA 483 with seven significant observations. The findings indicate a lack of adherence to essential quality system requirements, critical for ensuring device safety and efficacy.

Key violations include the absence of written procedures for Medical Device Reporting (MDR) and a failure to establish fundamental device documentation such as a Device Master Record (DMR), Design History File (DHF) for various device models, and proper procedures for Device History Records (DHR). These omissions suggest a systemic gap in controlling and documenting product design, manufacturing, and post-market surveillance activities. Additionally, the firm did not affix Unique Device Identifiers (UDI) to product labels, indicating non-compliance with device identification regulations, and lacked established procedures for adequate statistical sampling methods during production.

Furthermore, executive management had not ensured that the company's quality policy was understood, implemented, and maintained throughout the organization. These observations highlight broad non-conformance with the FDA's Quality System Regulation. Seattle Bioceramics, Inc. is expected to address these deficiencies by implementing comprehensive corrective actions to align with regulatory standards.