ARCADLAB LLCSeptember 1, 2023

FDA 483 - ARCADLAB LLC - September 01, 2023

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Record Details

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.

Company: ARCADLAB LLC
Inspection Date: September 1, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Gisselle I. Sensebe

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ID · 2c1df353-51bd-491a-b923-ae45828e3a3c