483
Sequoia Dental Studio, LLCSequoia Dental Studio, LLC – FDA 483, May 21, 2025
Record Details
An FDA inspection of Sequoia Dental Studio, LLC, a medical device specification developer in Westmont, IL, revealed significant deficiencies in their quality system. The firm lacked established procedures for critical processes like CAPA, complaint handling, and purchasing controls, and failed to implement written Medical Device Reporting (MDR) procedures. These issues are particularly concerning as several were repeat observations from a previous inspection.
- Office
- Chicago District Office
- Person
View Company Profile
ID · 5436a75f-ec2f-48a2-87f7-9c62adcd067a
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.