FDA WARNING_LETTER - Top Health Manufacturing, LLC - October 20, 2023

On June 3, 2024, the FDA issued a Warning Letter to Mr. Ung and Ms. Rudd of 1350 Calpac Avenue, Spanish Fork, UT, following an inspection of their dietary supplement manufacturing facility from October 12-13, 16, 18, and 20, 2023. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 111, rendering their dietary supplements, specifically "Grandma’s Herbs Kidney" and "(b)(4)," adulterated and misbranded.

Key violations include: **Adulterated Dietary Supplements (CGMP violations):** 1. Failure to follow written procedures for quality control operations (21 CFR 111.103). 2. Failure to establish required specifications for raw materials. 3. Failure to establish specifications for identity, purity, strength, and composition of finished batches (21 CFR 111.70(e)). 4. Failure to establish Master Manufacturing Records (MMRs) with all required elements (21 CFR 111.210). 5. Batch production records lacked complete information (21 CFR 111.255(b), 21 CFR 111.260).

The company's November