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WARNING LETTER

Flax & More Corporation MARCS-CMS 722845 —

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 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. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement you manufacture to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you do not have product specifications for the identity, purity, strength, and composition of your (b)(4) finished dietary supplement products that you manufacture.

We have reviewed your response to the FDA Form 483, dated November 20, 2025, and find it inadequately addresses the violation. In your response, you provided the updated finished product specification sheet for the (b)(4) dietary supplement that you manufacture. Specifications for the strength and composition of the product were established; however, you did not establish specifications for identity and purity. You provided the strength values for each ingredient in the finished product; however, you did not provide the methodology used to determine the strength.

We note that the finished product specification sheet for your product is not consistent with the label claims. For example, the product label claims (b)(4); however, the product specification sheet does not include specifications for (b)(4). In addition, your response stated that you created comprehensive product specifications for all finished products; however, you provided product specifications for only the (b)(4) product.

3. You failed to ensure that each master manufacturing record included the required elements in accordance with 21 CFR 111.210. Specifically, your master manufacturing record for (b)(4) failed to include the following required elements of 21 CFR 111.210:

  • A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]; and 
  • Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 11.210(h)(2)].

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #722845 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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