FDA 483 - LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD) - October 28, 2021
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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.
- Inspection Date
- October 28, 2021
- Product Type
- Device
ID · 585e5419-1777-4ef2-af9f-3b244971c5dc