FDA 483 - Hit Promotional Products Inc. - August 02, 2019

Hit Promotional Products Inc., an OTC Drug Product Labeler in Saint Petersburg, FL, was cited for significant deficiencies in its quality control unit. The inspection revealed a lack of cGMP systems, inadequate written procedures for critical operations like complaint handling and product release, and insufficient training and validation protocols. These issues indicate a systemic failure to ensure product quality and compliance.