FDA 483 - Stream2Sea, LLC - July 15, 2025

Stream2Sea, LLC, a drug manufacturer in Bowling Green, FL, was cited for significant deficiencies in its quality system, laboratory controls, equipment cleaning, and material identification during an FDA inspection. Repeat observations included issues with the quality control unit and cleaning validation, indicating a systemic lack of adherence to CGMP requirements for OTC drug products. The firm failed to conduct essential analytical and microbiological testing, validate methods, and properly qualify suppliers, leading to the release of untested products.