FDA 483 - Talisman LLC dba American Metabolix - January 31, 2024

An FDA inspection of Talisman LLC dba American Metabolix, an own label distributor of dietary supplements in Richardson, TX, revealed significant deficiencies. The firm failed to establish written procedures for critical quality control operations, including ensuring product quality and cGMP compliance. Additionally, the inspection found a lack of written procedures for holding and distributing products, as well as for the review and investigation of product complaints.