Unilever Manufacturing (US), Inc. – FDA 483, Sep 15, 2025

The FDA inspected Unilever Manufacturing (US), Inc. in Jonesboro, AR, an OTC drug manufacturer. The inspection revealed significant deficiencies in the firm's quality system and laboratory controls, including inadequate investigations into out-of-specification results, lack of quality unit oversight for procedures and change control, and issues with stability sample storage and microbiology testing methods. These findings indicate a lack of robust controls over critical manufacturing and testing processes.