FDA 483 - Conair LLC - October 22, 2025

An FDA inspection of Conair LLC in Stamford, CT, a specification developer and complaint file establishment, identified two significant observations. The firm failed to adequately establish procedures for internal quality system audits, with no audits conducted since 2015, and also failed to adequately establish procedures for management review, with no reviews documented since 2022. These issues indicate a lack of adherence to established quality system requirements.