FDA WARNING_LETTER - Stream2Sea, LLC - July 15, 2025

Stream2Sea, LLC, located in Bowling Green, Florida, received an FDA warning letter following an inspection conducted from July 9 to 15, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, which are the federal standards for ensuring drug quality and safety. Under the Federal Food, Drug, and Cosmetic Act, these violations classify the company’s over-the-counter (OTC) products as adulterated. The main issues involve a lack of adequate testing. Specifically, the company failed to test finished drug products for identity and strength before they were shipped to consumers. Furthermore, the firm did not verify the identity of incoming raw materials, relying instead on supplier documentation without a proper qualification process. Investigators also found that cleaning procedures for equipment shared between cosmetics and drugs were not properly validated, creating a risk of cross-contamination. Because the company"s initial response was insufficient, the FDA requires several immediate actions. Stream2Sea must conduct independent reviews of its laboratory practices, material systems, and cleaning protocols. They must also provide a plan for testing currently distributed products and are strongly encouraged to hire a professional consultant to ensure future compliance. The company has 15 working days to respond with a detailed remediation plan to avoid potential legal action, such as product seizures or manufacturing injunctions.