What happened
Original notice title
Flax & More Corporation MARCS-CMS 722845, May 12, 2026
From the archived source record
Based on inspectional findings we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. 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). Your response is not sufficient in that you did not submit any evidence of corrective and preventive actions by providing copies of your updated cleaning SOPs or photos indicating that the hopper used in manufacture of your dietary supplement products has seams that are smoothly bonded to prevent accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants, and that your cleaning and sanitizing procedures are effective. 2. We have reviewed your response to the FDA Form 483, dated November 20, 2025, and find it inadequately addresses the violation.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 327ff3822be9
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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