Creative Werks LLC – FDA 483, Jan 22, 2026

Creative Werks LLC, an OTC drug product labeler/packer in Elk Grove Village, IL, was cited for significant deficiencies in its quality system. The inspection revealed a widespread failure to establish written procedures for critical aspects of drug product manufacturing, including production, process controls, packaging, labeling, quality control, warehousing, and change control. Additionally, the firm's employees lacked adequate drug-specific cGMP training, leading to documentation errors and quality holds related to incorrect labeling.