FDA Cites Nutratech, LLC in 2026-06-04 Warning Letter — CGMP/Dietary Supplement/Adulterated/Misbranded
Letter issued · posted to fda.gov .
Subject as published: CGMP/Dietary Supplement/Adulterated/Misbranded
TL;DR
The FDA issued a warning letter to Nutratech, LLC (CMS #723021) on June 4, 2026, following an inspection of its Phoenix, NY facility from September 22 through October 15, 2025, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements under 21 CFR Part 111. The violations include failure to implement adequate hygienic practices (employees with bare arms handling ready-to-eat products, inadequate hand washing facilities, ill employees not removed from production, jewelry and street clothing worn in manufacturing areas) and failure to maintain sanitary facility conditions (encrusted food residues, loose cobwebs, improperly stored and open component containers in production areas). The FDA stated it cannot evaluate the adequacy of Nutratech's corrective action responses due to insufficient documentation submitted and will assess corrective actions during the next inspection.
Argus analysis
# FDA Warning Letter Analysis: Nutratech, LLC
**Company Overview and Violations**
Nutratech, LLC, a dietary supplement manufacturer based in Phoenix, New York, received a Warning Letter from the FDA's Human Foods Program on June 4, 2026, following an inspection conducted September 22 through October 15, 2025. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, resulting in findings that the company's products are adulterated under federal law. The violations span hygiene practices, facility maintenance, equipment standards, and product specifications.
**Regulatory Citations and Meaning**
The violations reference 21 CFR Part 111, the dietary supplement CGMP regulation. Specifically: 21 CFR 111.10(b) requires hygienic practices to prevent contamination—Nutratech's failures included incomplete hand-washing protocols, unavailable handwashing stations, and inadequate response to employee illness. 21 CFR 111.15(b) mandates clean, sanitary facilities; the company's production areas showed encrusted residues, cobwebs, and improperly stored components. 21 CFR 111.27(a) governs equipment design and maintenance; inspectors documented equipment with food-residue buildup and non-food-grade storage containers. 21 CFR 111.70(e) requires established product specifications for identity and purity; Nutratech relied solely on organoleptic (sensory) testing, insufficient for multi-ingredient products.
**Expected Next Steps**
Nutratech received responses dated through February 18, 2026, but the FDA noted the company failed to provide documentation supporting claimed corrective actions—no cleaning logs, photos, training records, or verification results were submitted. The FDA indicated it will reassess corrective action adequacy during a future inspection. Compliance officers monitoring this case should watch for follow-up inspection scheduling and any voluntary recalls or import alerts, which commonly follow unresolved CGMP Warning Letters in the dietary supplement sector.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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 Nutratech, LLC MARCS-CMS 723021 — June 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 C…
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 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 Nutratech, LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Nutratech, LLC as of 2026-07-14. Argus ingests new FDA enforcement records daily.
- What FDA violations was Nutratech, LLC cited for?
- The FDA Warning Letter to Nutratech, LLC (issuing office: Human Foods Program) cites: CGMP/Dietary Supplement/Adulterated/Misbranded. Classification: CGMP — Current Good Manufacturing Practice.
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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 Nutratech, LLC in 2026-06-04 Warning Letter — CGMP/Dietary Supplement/Adulterated/Misbranded. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-nutratech-llc-2026-06-04-cgmp
"FDA Cites Nutratech, LLC in 2026-06-04 Warning Letter — CGMP/Dietary Supplement/Adulterated/Misbranded." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-nutratech-llc-2026-06-04-cgmp.
Argus HQ Research. "FDA Cites Nutratech, LLC in 2026-06-04 Warning Letter — CGMP/Dietary Supplement/Adulterated/Misbranded." Digital Empire LLC. Accessed July 16, 2026. https://argushq.ai/fda/warning-letter/fda-wl-nutratech-llc-2026-06-04-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_nutratech_llc_2026_06_04_cgmp_2026,
title = {FDA Cites Nutratech, LLC in 2026-06-04 Warning Letter — CGMP/Dietary Supplement/Adulterated/Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-nutratech-llc-2026-06-04-cgmp},
note = {Accessed: July 16, 2026}
}