FDA 483 - Anatomy Supply Partners, LLC - August 01, 2025
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An FDA inspection of ASP Global, LLC. dba Anatomy Supply Partners, LLC. in Austell, GA, revealed significant deficiencies in their quality system. The firm failed to adequately manage suppliers, report medical device adverse events (MDRs) within 30 days, and report device corrections or removals to the FDA. These issues are related to their Safe-T-Fill Micro Capillary Collection Tubes, which have been linked to false positive lead results, potentially delaying critical diagnoses in pediatric patients.
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