FDA 483 - Kenvue Brands LLC - February 10, 2026

During an inspection of Kenvue Brands LLC in Fort Washington, PA, an OTC drug manufacturer, the FDA observed significant deficiencies in facility maintenance and adherence to written procedures. These issues included unsealed ceilings, unsmooth equipment surfaces, and uncontrolled cleaning liquid spills in controlled manufacturing areas, posing a risk of product contamination. Additionally, the firm failed to follow established cleaning and sanitization procedures, leading to microbial contamination of a drug product batch and compromised HEPA filters.