# FDA 483 - ARCADLAB LLC - September 01, 2023

Source: https://www.keypedia.com/records/483/arcadlab-llc/2c1df353-51bd-491a-b923-ae45828e3a3c

> FDA 483 for ARCADLAB LLC on September 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARCADLAB LLC
- Inspection Date: 2023-09-01
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: ARCADLAB LLC, a manufacturer of Arcad aligners and software in West Palm Beach, FL, was cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures and documentation for design controls, device history records, and management reviews. These issues indicate a systemic failure to adhere to regulatory requirements for medical device manufacturing.

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Company: https://www.keypedia.com/companies/arcadlab-llc/8e5af6a9-acf7-48d3-96c7-9a85dfbda909

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6