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  1. Warning Letters

WARNING LETTER

Wellmill, LLC dba Vitamix Laboratories MARCS-CMS 725655 —

Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Michael W. Koschitz
Recipient Title
President
Wellmill, LLC dba Vitamix Laboratories

106 Lake Ave S Suite 4-5
Nesconset, NY 11767
United States

(b)(6), (b)(7)(C)
Issuing Office:
Human Foods Program

United States

April 20, 2026

WARNING LETTER

Re: CMS 725655

Dear Mr. Koschitz:

The United States Food and Drug Administration (FDA) inspected your juice processing and dietary supplement manufacturing facility, located at 106 Lake Ave S Suite 4-5, Nesconset, NY, from December 3, 2025, through December 12, 2025. During our inspection, the FDA investigator observed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120).

Based on FDA's inspectional findings, we have determined that your (b)(4) and (b)(4) products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Juice HACCP regulation through links in FDA's home page at www.fda.gov.

At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility. We received your responses to the FDA-483 on January 16, 2026, March 12, 2026, March 17, 2026, March 30, 2026, and April 6, 2026, describing corrective actions taken or planned by your firm. Your response also states that you will no longer manufacture and label (b)(4) products as dietary supplements and (b)(4). Your April 6, 2026, response included revised labels for (b)(4) and (b)(4) reflecting this change.

We acknowledge your statement that you no longer intend to market these products as dietary supplements and your provision of revised labels for (b)(4) and (b)(4). However, should you market these or similar products in the future as dietary supplements, they would be subject to the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111), in addition to all other applicable regulatory requirements, including the juice HACCP regulations (21 CFR Part 120) as further discussed in this letter.

Based on our review of the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

Your significant violation is as follows:

Juice HACCP (21 CFR Part 120)

You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice you produce, as required by 21 CFR 120.7(a). Your firm did not conduct an adequate hazard analysis or have a HACCP plan appropriate for the juice products, (b)(4) and (b)(4), that you produce.

Your firm receives ready-to-use, shelf-stable (b)(4) juice blends and mixes the juice with a probiotic blend, producing ready-to-use (b)(4) juice with probiotics products. The product is blended and packaged under non-aseptic conditions at ambient temperature in your facility. The product does not undergo further processing to treat the product for pertinent organisms at your facility.

As a secondary juice processor engaged in blending and packaging operations as defined in 21 CFR 120.3(j) and 120.3(k), you are subject to the HACCP regulation and must conduct a comprehensive hazard analysis addressing all hazards introduced or reasonably likely to occur during your processing operations. Further, you must have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as required by 21 CFR 120.8(a).

Your hazard analysis must identify the following hazards that are reasonably likely to occur:

  • Biological hazards: Environmental contamination with pathogenic microorganisms (including Salmonella, E. coli O157:H7, Listeria monocytogenes, or other vegetative bacterial pathogens) during non-aseptic blending and bottling operations with no subsequent pathogen reduction step. Ready-to-drink juice is exposed to the processing environment during blending and bottling under non-aseptic, ambient conditions for approximately (b)(4) during sequential lot production, with additional ambient holding prior to (b)(4).
  • Biological hazards: Bacterial growth and/or toxin formation due to time and temperature abuse. According to product specifications provided in your response, the juice blend pH ranges from (b)(4). Some pathogens such as Salmonella and pathogenic strains of E. coli are capable of growth and toxin production at pH above 4.0 (3.7 for Salmonella) and require time/temperature control for safety1. Your product is opened, blended, and used to manufacture (b)(4) lots over approximately (b)(4) at ambient temperature, followed by additional ambient holding prior to (b)(4), with no documented control of actual room temperature. Under these conditions, bacterial growth may be reasonably likely to occur and must be evaluated in your hazard analysis.
  • Physical hazards: Glass fragments associated with filling into glass bottles. Your product is filled into glass containers, and accordingly, the physical hazard of glass fragments is reasonably likely to occur and must be identified in your hazard analysis with corresponding critical control point(s) in your HACCP plan. Appropriate controls such as container inspection, bottle integrity checks, glass breakage SOP(s), or other validated measures would need to be established and monitored at a CCP(s).

Your response states that you have conducted a hazard analysis on January 2, 2026, and concluded that no food hazards are reasonably likely to occur because hazards are adequately controlled through prerequisite programs including supplier verification, sanitation controls, environmental controls, equipment controls, and finished product testing. However, your response is inadequate. Your hazard analysis does not adequately address biological hazards from environmental contamination during non-aseptic blending and filling operations, biological hazards from pathogen growth due to time/temperature abuse during processing, and physical hazards (glass fragments) as product is bottled in glass containers. The receipt of a Certificate of Analysis from the supplier does not relieve you of your obligation to conduct your own hazard analysis addressing hazards introduced or reasonably likely to occur during your blending, ambient processing, and glass bottling operations. Your reliance on prerequisite programs, supplier verification, and finished product testing does not substitute for identifying hazards reasonably likely to occur and identifying control measures and critical control points, as required by 21 CFR 120.7.

Further, you must apply a process that achieves a 5-log reduction of the pertinent microorganism in the juice, to comply with 21 CFR 120.24(a). Under 21 CFR 120.24, processors must apply a 5-log reduction of the pertinent pathogen to juice in the facility where the final product is packaged. Your firm blends and fills the juice at ambient temperature without applying a process to produce the required minimum 5-log reduction at your facility. There is no indication that you have validated or are applying a control step to achieve the required 5-log reduction, nor that you have controls to prevent recontamination.

The single facility requirement under 21 CFR 120.24 mandates that juice processors apply the minimum 5-log pathogen reduction process and perform final product packaging within a single production facility operating under current good manufacturing practices. You have not demonstrated compliance with this requirement.

You state in your response that post-blending pathogen reduction treatments are not feasible as they would destroy probiotic viability. This does not substitute for compliance with the 5-log pathogen reduction requirement. A statement regarding product characteristics does not demonstrate compliance with regulatory requirements for pathogen reduction.

The violations cited in this letter are not intended to be an all-inclusive list 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 facility complies with all requirements of federal law, including FDA requirements.

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 by the FDA including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify FDA in writing, within fifteen (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 fifteen (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.

Please send your reply to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Tracy Li, Compliance Officer at tracy.li@fda.hhs.gov or by hardcopy to Food and Drug Administration, Attention: Tracy Li, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding this letter, you may contact Tracy Li, Compliance Officer, via email at tracy.li@fda.hhs.gov. Please include reference CMS 725655 in submissions and within the subject line of any of any email correspondence to the agency.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

________________________

1 Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Appendix 3: Bacterial Pathogen Growth and Inactivation, Table 3-A

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