Encore LaboratoryJanuary 9, 2026

FDA 483 - Encore Laboratory - January 09, 2026

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Record Details

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.

Company: Encore Laboratory
Inspection Date: January 9, 2026
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Alexandria L. Capuano (Investigator)

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ID · 5a9ec3c1-e29e-4b63-879f-c86b1cb5a216