FDA 483 - Bioplate Inc - June 01, 2026

Bioplate Inc, a manufacturer of neurosurgical devices in Placentia, CA, was cited for significant deficiencies across its quality management system. Observations included inadequate risk management records, insufficient feedback process documentation, poor control over outsourced manufacturing, and deficient corrective and preventive action procedures. The firm also lacked process validation records for a relocated product line, indicating systemic issues in ensuring product conformity and safety.