FDA 483 - Conair LLC - October 22, 2025

During an FDA inspection conducted from October 21-22, 2025, Conair LLC, a specification developer and complaint file establishment in Stamford, CT, received a Form FDA 483 for significant observations related to its quality management system. The inspection revealed that the company failed to adequately establish and follow procedures for critical quality processes. Specifically, Conair LLC's internal quality audits, which its procedure mandates annually, have not been performed since 2015. This constitutes a failure to uphold its own established quality assurance mechanisms. Furthermore, the firm's management review process, also required annually by its procedures, has lacked documentation since 2022. These lapses indicate a systemic issue in maintaining regulatory compliance and oversight of its quality system. The Form FDA 483 highlights deviations from the quality system requirements enforced by the Food and Drug Administration. Conair LLC acknowledged these findings and committed to implementing corrective actions to address both observations, ensuring future adherence to their internal procedures and regulatory expectations.