Loading…
Top Health Manufacturing, LLC received a warning for manufacturing adulterated dietary supplements, including "Grandma's Herbs Kidney" and another product, due to serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111. The facility failed to follow written quality control procedures, specifically SOP0301-1 regarding Quality Control Responsibilities, and did not ensure that Master Manufacturing Records were properly approved by the Quality Unit. These violations were identified during an FDA inspection conducted in October 2023 at the company's Spanish Fork, Utah manufacturing facility, and the violations rendered the dietary supplements adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.