FDA WARNING_LETTER - NAVEH PHARMA (1996) LTD - May 04, 2026

On May 4, 2026, the FDA issued a warning letter to Naveh Pharma LTD and Bigdam Inc. following a March 2026 review of their digital storefronts and a 2025 records assessment. The investigation revealed that the company is distributing unapproved new drugs, specifically “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%.” These products are marketed with claims to treat medical conditions such as respiratory syncytial virus (RSV), bronchiolitis, and cystic fibrosis. Under the Federal Food, Drug, and Cosmetic Act, products intended for the treatment or prevention of disease must undergo FDA review and approval to ensure safety and effectiveness before entering the market. Additionally, the FDA identified significant manufacturing violations at the company’s facility in Israel. The firm admitted to lacking a quality control unit, which is essential for overseeing the production and release of safe drug products. This failure to maintain a quality system violates Current Good Manufacturing Practice (CGMP) standards, causing the products to be legally classified as adulterated. To address these violations, the FDA requires the company to submit a comprehensive remediation plan that includes the establishment of a functional quality unit with proper oversight authority. Naveh Pharma must respond in writing within 15 working days detailing their corrective actions. Failure to resolve these issues promptly may lead to further regulatory enforcement, including product seizures or legal injunctions.