What happened
Original notice title
Western Herb Products, Inc. MARCS-CMS 615439, December 07, 2021
From the archived source record
During the inspection, we identified serious violations of Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (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. In addition, the Wormwood/Aloes dietary supplement product that you manufacture is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. We address your response below, in relation to each of the noted violations. Dietary Supplement CGMP Violations Your significant violations of CGMP requirements are as follows: 1. You failed to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required in 21 CFR 111.70(b)(3). b. 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 contaminants 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 component and finished product specifications regarding limits of contamination are inadequate because you did not specify which heavy metals are subject to the specification (component) or are not established (finished product).
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
- aa4c1e24926d
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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