Cosmax Nbt Usa, Inc. – FDA Warning Letter, May 4, 2021

The FDA issued a Warning Letter to Suk H. Cho following an inspection of their Garland, TX facility from April 6 to May 4, 2021. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. Failure to establish adequate finished product specifications for identity, purity, strength, composition, and contaminant limits for products like (b)(4) Multimineral (21 CFR 111.70(e)). 2. Failure to establish proper component specifications for purity, strength, and composition, and inadequate identity specifications for dietary ingredients (21 CFR 111.70(b)). 3. Failure to verify finished product specifications for contaminants like pesticides, specifically for (b)(4) Lot (b)(4), with discrepancies noted in testing dates and batch records (21 CFR 111.75(c)). 4. Failure to conduct identity testing for dietary ingredients before use, with instances of raw materials being used before testing (21 CFR 111.75(a)(1)(i)).

Additionally, products like (b)(4) and (b)(4) were deemed misbranded due to non-compliance with labeling requirements (21 CFR 101), including improper nutrition information presentation and failure to declare common