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Advanced Pharmaceutical Technology was cited for significant Current Good Manufacturing Practice (CGMP) violations at its Elmsford, NY facility during an inspection conducted July-August 2024, involving combination drug-device products that had been distributed in the United States since 2023. The company failed to establish and follow appropriate written procedures designed to prevent microbiological contamination, among other manufacturing control deficiencies that rendered the products adulterated under federal law. Notable enforcement context includes that the company only recently registered as a 503B Outsourcing Facility after already distributing these drug products commercially, and the FDA acknowledged the company's August 2024 response to inspection findings but determined the violations were not adequately addressed.