FDA 483 - Superior Felt & Filtration, L.L.C. - December 05, 2025

An FDA inspection of Superior Felt & Filtration, L.L.C. in McHenry, IL, a contract medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, and also lacked effective control over nonconforming materials. These issues indicate a lack of robust quality management for their respiratory filter accessories.