What happened
Original notice title
Top Health Manufacturing, LLC MARCS-CMS 671665, June 03, 2024
From the archived source record
Based on inspectional findings and review of the product labels collected during the inspection we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We acknowledge receipt of your correspondence received on November 10, 2023, and we address your response below, in relation to each of the noted violations. Adulterated Dietary Supplements The inspection of your facility on October 12-13, 16, 18, and 20, 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 supplements Grandma’s Herbs Kidney and (b)(4) 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 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 requirement area as follows: 1. You did not conduct periodic Good Manufacturing (GMP) internal audits of the entire plant with documented corrective actions, as required by your SOP 0301-0, section 4.1.13. Misbranded Dietary Supplements In addition, we reviewed your products labels collected during the inspection and have determined the Grandma’s Herbs Kidney and (b)(4) products you manufacture are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. The Grandma’s Herbs Kidney product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
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
- 8e5c92f4d7ec
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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