483
ARCADLAB LLCARCADLAB LLC – FDA 483, Sep 1, 2023
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.
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ID · 2c1df353-51bd-491a-b923-ae45828e3a3c
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