What happened
Original notice title
Formulation Technology, Inc. MARCS-CMS 672905, July 09, 2024
From the archived source record
Based on inspectional findings and review of the product labeling collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drug FDA reviewed product labeling for (b)(4) product following the inspection of your facility between October 24 and November 9, 2023. Adulterated Dietary Supplements The inspection of your facility on October 24, 2023, through November 9, 2023, identified significant violations of the FDA’s regulations for Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations Part 111 (21 CFR Part 111). These violations cause the dietary supplements 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. Specifically, these violations cause the (b)(4) product manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act. Also, in addition to being an unapproved new drug, your (b)(4) product is likewise an adulterated dietary supplement for the same reason. Your significant violations of dietary supplement cGMP requirements are as follows: 1. Specifically, during the inspection, the investigator noted that you failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3). These two components, which are used to manufacture the (b)(4) product, are botanicals and are at risk for heavy metal contamination. 2.
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
- 82d5f586b848
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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