FDA 483 - TBN Labs, LLC. - February 24, 2025

An FDA inspection of TBN Labs, LLC., a dietary supplements manufacturer in Hauppauge, NY, revealed multiple significant deficiencies in their quality control and manufacturing processes. The firm failed to establish and follow adequate laboratory controls for raw material identity and reference standards, qualify suppliers, and ensure finished product specifications, including heavy metal testing. Several critical observations were repeats from previous inspections, indicating a persistent lack of compliance.