FDA 483 - Kenvue Brands LLC - February 10, 2026

An FDA inspection of Kenvue Brands LLC in Fort Washington, PA, an OTC drug manufacturer, revealed significant deficiencies in facility maintenance and adherence to written procedures. Inspectors observed unsealed ceilings, rough equipment surfaces, and cleaning liquid pooling in controlled manufacturing areas, posing a risk of contamination. Additionally, the firm failed to follow established cleaning and sanitization procedures, including using unauthorized equipment, which led to microbial contamination and HEPA filter issues.