FDA 483 - Encore Laboratory - January 09, 2026

Encore Laboratory in Santa Ana, CA, was inspected from January 7-9, 2026, and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate device history records, nonconformance control, complaint handling, and a complete lack of internal quality audits. Additionally, the firm failed to apply Unique Device Identifiers (UDI) to its night guard products.