FDA 483 - ARCADLAB LLC - September 01, 2023

An FDA inspection of ARCADLAB LLC, a manufacturer of Arcad aligners and software, was conducted from August 29 to September 1, 2023. This inspection resulted in the issuance of a Form FDA-483, detailing significant observations concerning the company's quality management system, as mandated by the Federal Food, Drug and Cosmetic Act.

Key issues identified include the lack of established procedures for design control. Specifically, the firm failed to formally document critical aspects of design and development, such as planning, inputs, outputs, reviews, verifications, validations, and transfers for its products. Additionally, Design History Files were not adequately maintained to demonstrate that designs were developed according to approved plans.

Another significant observation noted that procedures for device history records had not been established. ARCADLAB LLC did not maintain comprehensive records for each Arcad aligner system, failing to document essential manufacturing details including dates, quantities, release information, acceptance records, and unique device identifiers.

Finally, the inspection revealed that the results and dates of management reviews were not properly documented, with critical elements like signed cover pages, agendas, attendee records, and meeting certifications missing. ARCADLAB LLC has committed to correcting all identified observations, which requires the development and implementation of comprehensive corrective actions to address these deficiencies and ensure full regulatory compliance.