FDA Cites Flax & More Corporation in 2026-05-12 Warning Letter — CGMP/Dietary Supplement/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Dietary Supplement/Adulterated
TL;DR
At a glance: The FDA's Human Foods Program issued a warning letter to Flax & More Corporation (CMS #722845, May 12, 2026) following an October 21–29, 2025 inspection of its Cutler Bay, Florida facility, citing three significant CGMP violations under 21 CFR Part 111 that render dietary supplements adulterated: equipment seams with accumulated residue and cross-allergen contamination risk; missing product specifications for identity and purity with methodology gaps and label-specification inconsistencies; and incomplete master manufacturing records lacking theoretical yield thresholds and sampling procedures. The FDA found the company's November 2025 responses insufficient due to lack of documentary evidence of corrective actions, updated procedures, or specifications for all products.
Argus analysis
# FDA Warning Letter: Flax & More Corporation
**Company and Findings**
The FDA's Human Foods Program issued a warning letter to Flax & More Corporation (Cutler Bay, Florida) on May 12, 2026, following an October 2025 inspection. The agency identified significant current Good Manufacturing Practice (CGMP) violations in dietary supplement manufacturing that render finished products adulterated under the Federal Food, Drug, and Cosmetic Act. The inspection documented three major deficiencies spanning equipment sanitation, product specifications, and manufacturing documentation.
**Regulatory Citations**
The violations center on 21 CFR Part 111, which establishes CGMP standards for dietary supplement manufacturers. Specifically: 21 CFR 111.27(a)(4) requires equipment seams to be smoothly bonded to prevent contamination accumulation—the company's hopper retained supplement residue after cleaning, with particular concern regarding cross-contamination of allergen-free products with wheat bran material. 21 CFR 111.70(e) mandates finished product specifications for identity, purity, strength, and composition; Flax & More provided incomplete specifications lacking methodology and identity/purity parameters, with discrepancies between label claims and documented specifications. 21 CFR 111.210 requires master manufacturing records to include theoretical yield thresholds and sampling procedures; the company's records omitted these elements.
**Response Timeline and Industry Watch Points**
The company had 15 working days from May 12 to submit written corrective actions, evidence of remediation, and documentation. Compliance officers in dietary supplement manufacturing should monitor whether Flax & More publishes recalls or receives follow-up enforcement actions. The FDA's emphasis on incomplete corrective responses (the company's first 483 response lacked supporting documentation) signals the agency's expectation for substantive, evidence-based compliance submissions rather than procedural acknowledgments alone.
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 Flax & More Corporation MARCS-CMS 722845 — May 12, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Recipient: Recipient Name Leonard Titayevsky Flax & More Corporation 10871 SW 188th St Unit 24 Cutler Bay , FL 33157-6801 United States Issuing Office: Human Foods Program United States May 12, 2026 WARNING LETTER CMS #722845 Dear Mr. Titayevsky: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, on October 21 through 29, 2025. Based on inspectional findings we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov. At the conclusion of the inspection on October 29, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated November 20, 2025, and we address your response below. Adulterated Dietary Supplements The inspection of your facility on October 21 through 29, 2025, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements, including (b)(4) products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1. You failed to ensure equipment and utensils you use have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants, as required by 21 CFR 111.27(a)(4). Specifically, the hopper used on October 20, 2025, to manufacture dietary supplement product (b)(4) (lot (b)(4) ) and was cleaned and sanitized (b)(4) . However, on October 21, 2025, the hopper was observed to have an accumulation of dietary supplement residue in the seams of the equipment. Furthermore, (b)(4) (lot (b)(4) ), is a product that contains the allergen wheat bran and you manufacture products that do not contain this ingredient on shared equipment. We have reviewed your response to the FDA Form 483, dated November 17, 2025. In your response, you stated that you reviewed and made corrections to your sanitation procedures and logs and retrained staff. You also stated that you implemented (b)(4) sanitation inspections and conduct reviews of your cleaning logs. Your response is not sufficient in that you did n…
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 Flax & More Corporation had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Flax & More Corporation as of 2026-06-30. 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). FDA Cites Flax & More Corporation in 2026-05-12 Warning Letter — CGMP/Dietary Supplement/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-flax-and-more-corporation-2026-05-12-cgmp
"FDA Cites Flax & More Corporation in 2026-05-12 Warning Letter — CGMP/Dietary Supplement/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-flax-and-more-corporation-2026-05-12-cgmp.
Argus HQ Research. "FDA Cites Flax & More Corporation in 2026-05-12 Warning Letter — CGMP/Dietary Supplement/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-flax-and-more-corporation-2026-05-12-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_flax_and_more_corporation_2026_05_12_cgmp_2026,
title = {FDA Cites Flax & More Corporation in 2026-05-12 Warning Letter — CGMP/Dietary Supplement/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-flax-and-more-corporation-2026-05-12-cgmp},
note = {Accessed: July 13, 2026}
}