FDA 483 - Cross Brands Contract Filling, LLC - June 10, 2019

An FDA inspection of Cross-Brands Manufacturing LLC in Rockledge, FL, an OTC drug product manufacturer, revealed numerous significant deficiencies in its quality control unit and manufacturing processes. The firm failed to establish and follow written procedures for critical operations, including component testing, microbial control, equipment cleaning, and product release. These widespread issues indicate a severe lack of adherence to Good Manufacturing Practices, posing potential risks to the quality and safety of their OTC drug products.