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WARNING LETTER

Nutratech, LLC MARCS-CMS 723021 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Philip R. Stone Jr.
Nutratech, LLC

67 County Route 59
Phoenix, NY 13135-2116
United States

Issuing Office:
Human Foods Program

United States

June 4, 2026

WARNING LETTER

CMS #723021

Dear Mr. Stone:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 67 County Route 59, Phoenix, NY on September 22 through October 15, 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 15, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated October 21, November 6, December 15, 2025, and February 18, 2026, and we address your responses below.

Adulterated Dietary Supplements

The inspection of your facility on September 22 through October 15, 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 supplement 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 use hygienic practices to the extent necessary to protect against such contamination of components, dietary supplements, or contact surfaces, as required in 21 CFR 111.10(b). Specifically, during the inspection, our investigator observed the following:

  • Employees were washing their hands with soap and water, but they did not wash their arms, which come in direct contact with ready-to-eat (RTE) product, nor did they use sanitizer after washing. Additionally, all hand washing was performed in the employee restroom, as the (b)(4) hand washing facilities in the hallway outside the supplement packaging rooms were full of bins, utensils, and other materials, and were not available for hand washing.
  • An employee reached into a bin containing the above RTE dietary supplement and her bare arms came in direct contact with the powder. Examination of the employee’s arms afterwards indicated an extensive amount of powder adhered to her arms.
  • Employees working with the above product were observed wearing jewelry and their street clothing.
  • A batch production record (BPR) contained a statement in the “Notes Continued” section that an employee, “is taking regular breaks; he is sneezing and coughing quite a bit. Had him take some medication for it, but it remains an issue. Having to go slow again.” You did not take appropriate corrective action when an employee was noted to be ill.

We have reviewed your responses to the FDA Form 483, dated October 22, November 6, December 15, 2025, and February 18, 2026, and we are unable to evaluate the adequacy of your corrective actions. In your response, you provided a corrective action and preventive action (CAPA) report for this 483 observation. The CAPA states that your immediate corrective actions were to restore the handwash stations, stock the soap and sanitizer, post signage, implement strict gowning, remove the ill employee, and conduct a fitness-for-work assessment. You state that your implementation evidence consists of photos and logs of the cleared stations, training records, pre-shift checks, and the development of an illness policy and incident logs. To date, you have not submitted to the FDA any of this evidence of corrective action by providing copies of relevant documentation or by providing photos indicating that the corrective actions have taken place. FDA will assess the adequacy of your corrective actions during our next inspection.

2. You failed to maintain the physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated, as required by 21 CFR 111.15(b). Specifically, during the inspection, our investigator observed the following:

  • The wooden platform beside the blender and walls in the powdered dietary supplement production room had a build-up of encrusted, dried food residues and soilage across their surfaces; and the ceiling had an extensive amount of hanging, loose cobwebs and misplaced/broken (b)(4) ceiling tiles above areas where exposed, RTE powdered dietary supplements were being manufactured.
  • There were numerous boxes and packs of dietary supplement components stored on pallets, the floor, and the wooden platform beside the blender in the northwest corner of the powdered supplement manufacturing room. These boxes and packs were observed to be improperly stored, open and partially open, piled on top of one another, and/or covered in apparent powdered components and cobwebs. One pack of (b)(4) powder was observed to have (b)(4) powder spilled into its (b)(4) powder.

We have reviewed your responses to the FDA Form 483, dated October 21, November 6, December 15, 2025, and February 18, 2026, and we are unable to evaluate the adequacy of your corrective actions. In your response, you provided CAPA reports for this 483 observation. The CAPA reports state that your immediate corrective actions were to deep clean production areas, remove residues and cobwebs, repair and replace damaged ceiling tiles and porous surfaces, organize components on racks/pallets, seal open containers, and dispose of compromised materials. In your February 18, 2026 response you provided copies of SOP-MAN-006-B3, “Master Sanitation Schedule Production Room,” and SOP-MAN-006-B5, “Master Sanitation Schedule Production Hallway.” However, you have not provided documentation of your corrective actions such as cleaning logs, pre/post photos, work order, sign-offs, calendars, verification records, environmental logs, training records, or disposition records. FDA will assess the adequacy of your corrective actions during our next inspection.

3. You failed to meet requirements of 21 CFR 111 Subpart D that apply to equipment and utensils. Specifically, you failed to use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained, as required by 21 CFR 111.27(a). For example, during the inspection while you were manufacturing (b)(4) dietary supplement products, our investigator observed the following:

  • (b)(4) scoops were staged on the production line in a box constructed of non-food grade material in disrepair with large cracks. These scoops are included inside each package of RTE dietary supplement powder.
  • The filler machine hopper was covered with cardboard squares. These cardboard squares were stored next to the filler machine directly on the floor.
  • The (b)(4) scoop used to transfer powder to the filler machine had an extensive build-up of encrusted, dark, dried food residues across the handle, which is a (b)(4) contact surface.
  • The blender had an extensive build-up of 1/4-inch thick and hard pieces of apparent compacted dietary supplement powder inside the flanges above the discharge valve, which is beneath the mixer, and above where barrels are filled with exposed, RTE blended supplements.
  • BPRs for these products just state that, “Production room is clean” and “All utensils and production machines are clean” at the start of each production, with no further details.

We have reviewed your responses to the FDA Form 483, dated October 21, November 6, December 15, 2025, and February 18, 2026, and we are unable to evaluate the adequacy of your corrective actions. In your response, you provided CAPA reports for these 483 observations. The CAPA reports state that your immediate corrective actions were to stop production and deep clean the blender, filler, and scoops, verify with visual and ATP/swab before restarting, and review the calibration status for all scales. You state that your implementation evidence consists of updated SOPs, logs, cleaning records, ATP/swab results, a preventative maintenance schedule, photos, and calibration certificates. To date, you have not submitted to the FDA any of this evidence of corrective action by providing copies of relevant documentation or by providing photos indicating that the corrective actions have taken place. FDA will assess the adequacy of your corrective actions during our next inspection.

4. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you failed to establish product specifications for the identity, purity, strength, and composition of the (b)(4) dietary supplement products. You provided organoleptic identity specifications for the products (b)(4); however, these products contain many ingredients that may share the same organoleptic properties, and therefore the analysis of organoleptic factors alone will not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient in the product.

We have reviewed your responses to the FDA Form 483, dated October 21, November 6, December 15, 2025, and February 18, 2026, and find they inadequately address the violation with respect to your (b)(4) dietary supplement product. In your response, you provided a CAPA report for this 483 observation. The CAPA report states that your immediate corrective actions were to establish product-specific specifications for each dietary supplement, including numerical limits and test methods for identity (botanical identity of (b)(4)), purity (microbial limits; heavy metals; pesticides, as applicable), strength (labeled quantitative amounts), composition, and limits on contaminants and update all MMRs and batch production records to reference those specifications. You state that your implementation evidence consists of approved updated SOPs; approved specifications for each SKU, revised MMRs, and training records. The revised specifications you provided for (b)(4) do not meet the requirements of 21 CFR 111.70(e) in that they do not include specifications for the identity, purity, strength, and composition of the product.

Additionally, we are unable to evaluate the adequacy of your corrective action with respect to your (b)(4) dietary supplement products. You did not provide documentation to support that you have established product specifications for the (b)(4) dietary supplement products. FDA will assess the adequacy of your corrective actions during our next inspection.

5. Your written master manufacturing records are missing information required by 21 CFR 111.210. Specifically, the MMRs for the products (b)(4) are missing required information. For example, the MMRs fail to include written instructions for specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR (21 CFR 111.210(h)(3)).

We have reviewed your responses to the FDA Form 483, dated October 21, November 6, December 15, 2025, and February 18, 2026, and we are unable to evaluate the adequacy of your corrective actions. In your response, you provided a CAPA report for this 483 observation. The CAPA report states that your immediate corrective actions were to revise the MMR templates to include all elements, train production/QA employees, and enforcement document control. You state that your implementation evidence consists of revised MMRs, training records, and a control release notice. To date, you have not submitted to the FDA any of this evidence of corrective action by providing copies of relevant documentation indicating that the corrective actions have taken place. FDA will assess the adequacy of your corrective actions during our next inspection.

6. You failed to include necessary information in the batch production records, as required in 21 CFR 111.260. For example, the BPRs for the products (b)(4) failed to include:

  • The identity of equipment and processing lines used in producing the batch (21 CFR 111.260(b)).
  • The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to the records (21 CFR 111.260(c)).
  • A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f)).
  • The actual results obtained during monitoring (21 CFR 111.260(g)).

We have reviewed your responses to the FDA Form 483, dated October 21, November 6, December 15, 2025, and February 18, 2026, and we are unable to evaluate the adequacy of your corrective actions. In your response, you provided a CAPA report for this 483 observation. The CAPA report states that your immediate corrective actions were to stop using the legacy BPR and issue controlled updated BPRs with all 21 CFR 111.260 elements, including dual verification for weighing and addition of ingredients. You state that your implementation evidence consists of revised BPRs, completed records, verification initials, label attachments, and audit checklists. To date, you have not submitted to the FDA any of this evidence of corrective action by providing copies of relevant documentation indicating that the corrective actions have taken place. FDA will assess the adequacy of your corrective actions during our next inspection.

7. You failed to establish and follow written procedures for product complaints, and failed to review and investigate product complaints, as required by 21 CFR 111.553 and 21 CFR 111.560(a) respectively. Specifically, you failed to follow your written procedures for product complaints and failed to document the review and investigation of product complaints. Your firm has SOPs titled "Product Quality Handling Form Number: SOP-QAM 006" and "Customer Complaint Form Number: TEMP-SOP-QAM-006A" that you are to complete for all consumer complaints, including information on follow-up actions. You are not following these SOPs, as you did not have documents showing you investigated the (b)(4) complaints. When your customer (b)(4) requested production records as part of their complaint investigations of (b)(4) (Lots (b)(4) and (b)(4)), you provided (b)(4) the BPRs for these products including COAs, but no records of your complaint reviews and investigations were available.

We have reviewed your responses to the FDA Form 483, dated October 21, November 6, and December 15, 2025, and February 18, 2026, and we are unable to evaluate the adequacy of your corrective actions. In your response, you provided a CAPA report for this 483 observation. The CAPA report states that your immediate corrective actions were to revise your complaint handling SOP to align with 21 CFR 111.560, include an adverse event reporting decision tree, outline investigation requirements, and implement a complaint database with trend analysis. You state that your implementation evidence consists of a revised SOP, completed (b)(4) investigations and health hazard evaluations (HHEs), submitted/assessed adverse event reports (AERs), training logs, and trend reports. In your latest response you provided a copy of SOP titled "Product Quality Handling Form Number: SOP-QAM 006" and a revised copy of "Customer Complaint Form Number: TEMP-SOP-QAM-006A" that now requires quality to review and determine whether further investigation is necessary. However, we are unable to evaluate the adequacy of your corrective action because you did not provide documentation that you have reviewed and investigated the complaints received for (b)(4) Lots (b)(4) and (b)(4). FDA will assess the adequacy of your corrective actions during our next inspection.

Misbranded Dietary Supplements

In addition, we reviewed your product labels collected during the inspection and have determined (b)(4) product you manufacture is misbranded under section 403 of the Act [21 U.S.C. 343] because it does not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:

(b)(4) product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the product contains the ingredient (b)(4) and the label fails to declare the major food allergen “(b)(4)” present in the product, as required by section 403(w)(1) of the Act. Section 201(qq)) of the Act [21 U.S.C. 321(qq)] defines milk, egg, fish, Crustacean shellfish, sesame, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as "major food allergens." A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

  • The word "Contains" followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act, [21 U.S.C. 343(w)(1)(A)], or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “(b)(4)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. 343(w)(1)(B)].

This letter is not intended to be an all-inclusive statement of violations that may exist 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 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 #723021 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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