# FDA 483 - LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD) - October 28, 2021

Source: https://www.keypedia.com/records/483/late-night-concepts-inc-dba-brux-night-guard/585e5419-1777-4ef2-af9f-3b244971c5dc

> FDA 483 for LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD) on October 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD)
- Inspection Date: 2021-10-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Late Night Concepts Inc. dba Brux Night Guard, a medical device manufacturer in West Hills, CA, revealed significant deficiencies in their quality system. The firm failed to establish essential documentation, including a Design History File, Device History Records, and a Device Master Record. Additionally, the inspection found that quality audits had not been performed or maintained, indicating a broad lack of adherence to regulatory requirements.

## Related Documents

- [483 - 2023-10-26](https://www.keypedia.com/records/483/late-night-concepts-inc-dba-brux-night-guard/0eaed29d-513c-4bb3-970a-ba738a5b6a1d)

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/late-night-concepts-inc-dba-brux-night-guard/9b611173-5fc6-45fb-ae6f-2fc167919332

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