FDA WARNING_LETTER - ASP Global, LLC. - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to ASP Global, LLC. dba Anatomy Supply Partners, LLC., following an inspection from July 28 to August 1, 2025. The inspection at their Austell, Georgia facility revealed significant violations of the Quality System Regulation (21 CFR Part 820) for their medical device, the Safe-T-Fill Micro Capillary Collection System, deeming the devices adulterated under the Federal Food, Drug, and Cosmetic Act.

A primary violation was the failure to adequately establish procedures for purchased products and services (21 CFR 820.50). Specifically, ASP Global's supplier management for its critical manufacturer of Safe-T-Fill tubes was deficient, leading to products causing false positive lead test results due to manufacturing issues. Deficiencies included inadequate supplier evaluations, missed on-site audits, delayed notification of supplier's FDA observations, and insufficient verification of Design History Files. Additionally, the company marketed 300 μL Safe-T-Fill tubes for years without properly evaluating the need for new 510(k) clearance, despite only smaller volumes being originally cleared.

ASP Global's corrective action responses were found inadequate, lacking sufficient detail and supporting documentation. The FDA requires the company to implement robust corrective actions, including improved supplier controls, comprehensive audit criteria, thorough integration procedures for acquired firms, and proper assessment of legacy product changes and associated clearances, providing detailed evidence to ensure compliance and address patient safety concerns.