Cosmax NBT USA
FDA issued a warning letter to Cosmax NBT USA, a dietary supplement manufacturer in Garland, TX, following a 2021 facility inspection that revealed serious CGMP violations and labeling deficiencies. The company failed to establish adequate product and component specifications, verify component identity before use, and properly document pesticide testing, causing products to be adulterated under 21 CFR Part 111. Multiple finished products were also found misbranded due to non-compliant Supplement Facts labeling, including improper Daily Value declarations, missing ingredient common names, and erroneous calorie statements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (2)
Percent Daily Values based on a 2,000 calorie diet.
Vitamin D3
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. Include an explanation of each step being taken to prevent the recurrence of 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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