# FDA 483 - Encore Laboratory - January 09, 2026

Source: https://www.keypedia.com/records/483/encore-laboratory/5a9ec3c1-e29e-4b63-879f-c86b1cb5a216

> FDA 483 for Encore Laboratory on January 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Encore Laboratory
- Inspection Date: 2026-01-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/encore-laboratory/6ad45162-c76f-4898-9c47-4d43b7214f05

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6