What happened
Original notice title
Nupack Inc. MARCS-CMS 722113, March 20, 2026
From the archived source record
Based on inspectional findings and review of the product labels and labeling collected during the inspection, as well as review of your website, www.unitechusk.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs FDA reviewed your website at the Internet address www.unitechusk.com in August and September of 2025 and has determined that you take orders there for the products, Cardiag, Diabetech, Cleanse-CAMP, MACA, Kidney Cleanse, and Pure Pysyllium Husk. Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Cardiag, Diabetech, and MACA fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements The inspection of your facility on August 20, 2025, through September 24, 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 all of your dietary supplements, including the Cardiag, Cleanse-camp, and MACA 1000 mg 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.
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
- dddef6d47ac7
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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