483
LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD)LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD) – FDA 483, Oct 28, 2021
Record Details
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
View Company Profile
ID · 585e5419-1777-4ef2-af9f-3b244971c5dc
Other documents for LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD)
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.