FDA 483 - Hit Promotional Products Inc. - January 28, 2026

Hit Promotional Products Inc. in Saint Petersburg, FL, an OTC Human Drug Labeler, was cited for significant deficiencies during an FDA inspection. The firm lacks adequate written procedures for its quality control unit, production, process controls, and stability testing, leading to issues with label control, product specifications, and expiration date support. Additionally, the facility's warehouse lacks proper environmental controls and secure access, impacting drug product storage conditions.