Warning Letter Record: Naveh Pharma LTD/Bigdam Inc. (May 4, 2026) — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

FDA Warning Letter — Violations FDA cited at Naveh Pharma LTD/Bigdam Inc.

WARNING LETTER Naveh Pharma LTD/Bigdam Inc. MARCS-CMS 724669 — May 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Tal Bornstein, CEO Recipient Title Roei Farhi, CEO Naveh Pharma LTD/Bigdam Inc. 19, Yad Kharutsim St. Netanya, Sharon area Israel Tal@navehpharma.com info@navehpharma.com roei@navehpharma.com hello@u-better.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER May 4, 2026 Bigdam Inc 1441 Woodmont Ln NW, Atlanta GA 30318, United States RE: 724669 Dear Tal Bornstein and Roei Farhi: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites https://www.navehpharma.com/ and https://u-better.com/, and your Amazon storefront 1 in March 2026. The FDA has observed that you offer your products, “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). In addition, FDA reviewed the records you submitted in response to our initial April 28, 2025, request for records and other information, and subsequent correspondence, pursuant to section 704(a)(4) of the FD&C Act for your facility, Naveh Pharma (1966) LTD, FEI 3027300316, at 19 Yad Kharutsim, Netanya, Sharon Area, Israel. Unapproved New Drugs Based on a review of your websites, your “RSV Hypertonic Saline 3%” and “Hypertonic Saline 7%” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your websites that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: RSV Hypertonic Saline 3% From the “RSV Hypertonic Saline 3%” document 2 available on the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline/: “For treatment of Bronchiolitis (RSV - respiratory syncytial virus)” “In recent years quite a number of studies around the world, proved the effectiveness of treatment with Hypertonic saline inhalation in infants hospitalized suffering from acute bronchiolitis.” “Hypertonic saline inhalation therapy resulted in clinical improvement and shortening the duration of hospitalization.” “Hypertonic saline works by raising fluid lining in the airway walls, reducing the edema layer of the submucosa, improving Rheological properties of sputum and acceleration of the mucus clearance (MC).” “For respiratory use with inhalators in cases of bronchiolitis- RSV infections” On the webpage https://u-better.com/products/saline-solution-3-for-daily-inhalation-25-vials: “This 3% saline solution is ideal for nebulizer therapy and nasal irrigation. It helps clear mucus and supports easier breathing.” “Gentle On Airways And Clinically Sterile Saline (NaCl + water) That Helps Loosen Mucus and Hydrate Nasal & Respiratory Passages—For Clear, Comfortable Breathing.” The product name: “RSV Hypertonic Saline” Hypertonic Saline 7% On the webpage https://www.navehpharma.com/products/advanced-ent-line/hypertonic-saline-7/: “Hypertonic saline creates an osmotic pressure that increases the volume of airway surface liquid, restore mucus clearance, and improve lung function.” “Recent clinical studies in patients with cystic fibrosis, have shown that inhalation of hypertonic saline produced a sustained acceleration of mucus clearance and improved lung function. This treatment improves sputum visco