What happened
Original notice title
Nutratech, LLC MARCS-CMS 723021, June 04, 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 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). 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). 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. 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.
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
- 9c60925cbbc0
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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