Warning Letter — Stream2Sea, LLC
The FDA issued a warning letter to Stream2Sea, LLC following an inspection that identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals.
Stream2Sea, LLC, its manufacturing and quality control departments, and potentially other firms producing personal care products with therapeutic drug claims.
The issuance of a warning letter by CDER indicates that the FDA has identified systemic failures in the firm's ability to ensure product safety and quality. This suggests a lack of adequate Quality Unit oversight and may lead to restricted distribution or required remediation of manufacturing processes to align with drug standards.
Review manufacturing protocols to ensure all products marketed with therapeutic claims comply with cGMP requirements. Verify that quality units are actively monitoring production environments and that all finished products undergo validated testing for identity and strength before release.
FDA Warning Letter issued to: Stream2Sea, LLC. 02/02/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stream2sea-llc-718983-02022026
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