Naveh Pharma LTD/Bigdam Inc. — FDA Warning Letter, 2026-05-04: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
TL;DR
FDA issued a Warning Letter to Naveh Pharma LTD/Bigdam Inc. on 2026-05-04 citing: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naveh-pharma-ltdbigdam-inc-724669-05042026
Argus analysis
Naveh Pharma LTD/Bigdam Inc. (MARCS-CMS 724669, FEI 3027300316) received an FDA Warning Letter dated May 4, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 12, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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).” …
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Naveh Pharma LTD/Bigdam Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Naveh Pharma LTD/Bigdam Inc. as of 2026-05-12. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Naveh Pharma LTD/Bigdam Inc. — FDA Warning Letter, 2026-05-04: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-naveh-pharma-ltd-bigdam-inc-2026-05-04-cgmp
"Naveh Pharma LTD/Bigdam Inc. — FDA Warning Letter, 2026-05-04: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-naveh-pharma-ltd-bigdam-inc-2026-05-04-cgmp.
Argus HQ Research. "Naveh Pharma LTD/Bigdam Inc. — FDA Warning Letter, 2026-05-04: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-naveh-pharma-ltd-bigdam-inc-2026-05-04-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_naveh_pharma_ltd_bigdam_inc_2026_05_04_cgmp_2026,
title = {Naveh Pharma LTD/Bigdam Inc. — FDA Warning Letter, 2026-05-04: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-naveh-pharma-ltd-bigdam-inc-2026-05-04-cgmp},
note = {Accessed: July 13, 2026}
}