FDA 483 - Sequoia Dental Studio, LLC - May 21, 2025

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.