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ASP Global, LLC. dba Anatomy Supply Partners, LLC. manufactured the Safe-T-Fill Micro Capillary Collection System, a medical device intended for disease diagnosis and monitoring, which was found to be adulterated due to failures to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. During an inspection conducted July 28–August 1, 2025, the FDA identified multiple Quality System Regulation violations, including failure to establish adequate supplier management procedures to ensure that critical products purchased from the manufacturer of the Safe-T-Fill Capillary Collection Tubes conformed to specified requirements under 21 CFR 820.50. The company submitted a response to the FDA's Form 483 observations on August 22, 2025, but the violations remained unresolved.