FDA 483 - IH Biomedical - December 16, 2019

Implant Holdings LLC, a repackager/relabeler and initial importer of Class 2 dental implants and accessories in Olympia, WA, was cited for significant deficiencies in its quality management system. The firm failed to adequately establish or develop critical procedures for Medical Device Reporting, complaint handling, corrective and preventive actions, and the control of nonconforming product. These issues indicate a fundamental lack of documented processes essential for ensuring product quality and regulatory compliance.