Top Health Manufacturing, LLC
FDA issued a warning letter to Top Health Manufacturing, LLC (Spanish Fork, UT) following a October 2023 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations — including failures in quality control procedures, missing component and finished-product specifications, incomplete master manufacturing records, and deficient batch production records — causing products 'Grandma's Herbs Kidney' and a redacted product to be adulterated under 21 U.S.C. § 342(g)(1). Additionally, both products were found misbranded for labeling deficiencies including failure to identify plant parts for botanical ingredients, a false ingredient declaration (candelilla wax listed but not used), and non-compliant nutrition information formatting. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (4)
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). Specifically, you list the ingredients parsley, cleavers, and meadowsweet as "herb" and do not identify the plant part used in the product.
Allergy warning: Manufactured in facility that also handles milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybean.
the labeling is false or misleading. The product label identifies the ingredient "candelilla wax", but the batch record reviewed during the inspection for (b)(4), shows that candelilla wax was not added to the product despite the declaration on the label.
The product label does not list the quantitative weight of the proprietary blend using the appropriate units, which is not in accordance with 21 CFR 101.36(b)(3)(ii)(A).
Required actions (2)
Please notify this office in writing within 15 working days of the receipt of this letter of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent recurrence of the violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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