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

An FDA inspection of Seattle Bioceramics, Inc. in Kent, WA, a manufacturer of Purzir Dental Zirconia devices, revealed significant deficiencies across its quality system. The firm failed to establish and maintain critical procedures and records, including those for Medical Device Reporting, Device Master Records, Device History Records, Design History Files, and Unique Device Identifiers. These findings indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.