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

Source: https://www.globalkeysolutions.net/records/483/sequoia-dental-studio-llc/5436a75f-ec2f-48a2-87f7-9c62adcd067a

> FDA 483 for Sequoia Dental Studio, LLC on May 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sequoia Dental Studio, LLC
- Inspection Date: 2025-05-21
- Product Type: device
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

Company: https://www.globalkeysolutions.net/companies/sequoia-dental-studio-llc/a3c1a47e-c6fc-4610-bc15-4af3ac70c219

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669