TBN Labs, LLC. – FDA 483, Feb 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.
ID · 6ca2408c-8512-4d04-a8bc-caca760b4d97
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