Zing Brothers LLC
FDA issued a warning letter to Zing Brothers LLC (Salt Lake City, UT) following an August 2022 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations including failure to establish component and product specifications, lack of written quality control procedures, missing master manufacturing records, and incomplete batch production records. Additionally, two products were found misbranded because their labels falsely claimed ingredients not present in formulations, failed to declare actual ingredients, omitted artificial coloring disclosures, presented nutrition information incorrectly, and lacked a domestic contact address for adverse event reporting. FDA warned that failure to correct these violations may result in seizure or injunction.
Flagged claims (4)
these product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4
the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
the product contains artificial coloring but fails to bear labeling stating that fact
the product labels state that the products contain (b)(4), and "(b)(4)". This information is false because your BPRs do not include these ingredients as part of the formulation for these products.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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