483
Encore LaboratoryEncore Laboratory – FDA 483, Jan 9, 2026
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.
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ID · 5a9ec3c1-e29e-4b63-879f-c86b1cb5a216
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