What happened
Original notice title
Oregon’s Wild Harvest, Inc. MARCS-CMS 621842, August 08, 2022
From the archived source record
The inspection revealed serious violations of 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 your dietary supplement products, including Stress Guard, Aller-Aid, Eyes Love Lutein, TumeriPro, Prostate Health, Kids Tranquil Child, Kids Echinacea Goldenseal, CountToZen, Milk Thistle Elixir, Ashwagandha Gingko, Sleep Better, Hawthorn, Bilberry, Cordyceps, and Black Cohosh to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. We address your responses below, in relation to the noted violations. Your significant violations of CGMP requirements are as follows: 1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for 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(e). Your quality control personnel failed to reject a component or dietary supplement when an unanticipated occurrence took place during the production and in-process control systems that results in or could lead to the adulteration of a component or dietary supplement, as required by 21 CFR 111.113(b)(1). Your investigation for Milk Thistle Seed COG Whole component lot (b)(4) contaminated with wheat grains demonstrates that (b)(4) removing the visible allergen from the component does not necessarily completely remove the allergen from the component.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 8d41d7c34455
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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