Top Health Manufacturing, LLC

Warning LetterOpen

Mr. Mathieu Q C Ung, Co-Owner Ms. Cynthia L. Rudd, Co-Owner Top Health Manufacturing, LLC 1350 Calpac Avenue Spanish Fork , UT 84660-9298 United StatesFEI 3015283754Issued Jun 3, 2024Division of Human and Animal Food Operations West IV

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3015283754.

Violations10

Issue DateJun 3, 2024

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Top Health Manufacturing, LLC
Location: Mr. Mathieu Q C Ung, Co-Owner Ms. Cynthia L. Rudd, Co-Owner Top Health Manufacturing, LLC 1350 Calpac Avenue Spanish Fork , UT 84660-9298 United States
FEI Number: 3015283754
Country: United States
Issue Date: June 03, 2024
Issuing Office: Division of Human and Animal Food Operations West IV
Product Type: Dietary Supplements
Status: Open

Summary

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.

Top Health Manufacturing, LLC FDA Warning Letter, June 3, 2024