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 in its quality control unit, production and process controls, and facility conditions. The inspection revealed a lack of written procedures for critical operations like label control, complaint handling, deviation management, and product recalls, as well as inadequate stability testing and environmental controls in the warehouse. These issues indicate a systemic failure to ensure the identity, strength, purity, and quality of their OTC drug products.