Cosmax NBT USA

Warning LetterClosed

Suk H. Cho Chief Executive Officer Cosmax NBT USA 3350 Marquis Dr. Garland , TX 75042 United StatesFEI 3011589479Issued May 3, 2023Division of Human and Animal Food Operations West III

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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 3011589479.

Letter Details

Firm: Cosmax NBT USA
Location: Suk H. Cho Chief Executive Officer Cosmax NBT USA 3350 Marquis Dr. Garland , TX 75042 United States
FEI Number: 3011589479
Country: United States
Issue Date: May 03, 2023
Issuing Office: Division of Human and Animal Food Operations West III
Product Type: Dietary Supplements
Status: Closed
Closeout Letter: December 05, 2023

Summary

Cosmax NBT USA, a dietary supplement manufacturer in Garland, Texas, failed to establish required product specifications for identity, purity, strength, and composition of finished batches, including a multimineral product, in violation of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR 111.70(e). The inspection conducted from April through May 2021 identified serious violations of the Federal Food, Drug, and Cosmetic Act that rendered the dietary supplements adulterated because they were prepared and held under conditions that did not meet FDA's CGMP requirements. The company submitted multiple written responses between May 2021 and July 2022 attempting to address the FDA's inspectional observations, but the violations were deemed serious enough to warrant the warning letter issued in May 2023.