# FDA 483 - Joylux, Inc. - June 15, 2026

Source: https://www.keypedia.com/records/483/joylux-inc/8aaee0b5-cc36-4b4c-8cd6-612a25b718b4

> FDA 483 for Joylux, Inc. on June 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joylux, Inc.
- Inspection Date: 2026-06-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Joylux, Inc., a medical device specification developer in Seattle, WA, received a Form FDA 483 with two observations. The firm was cited for failing to ensure medical devices had unique device identifiers (UDI) on their labels and for not adequately documenting procedures for timely complaint handling. These observations highlight deficiencies in the firm's quality system for medical devices.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/joylux-inc/7149caf0-247d-4563-be75-c05557bd79b0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822