FDA 483 - Talisman LLC dba American Metabolix - January 31, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 28381907-805e-4c64-bee2-135909fb1ac1