FDA 483 - Apollo Care, LLC - July 28, 2026

Between July 13 and July 28, 2026, the FDA inspected Apollo Care, LLC, a 503B outsourcing facility in Columbia, Missouri. The inspection identified several significant violations of the Federal Food, Drug, and Cosmetic Act, many of which were repeat offenses. A primary concern was the failure of the quality control unit to investigate visible white particles found in multiple lots of injectable Semaglutide. Furthermore, the facility failed to maintain sterile conditions, as evidenced by turbulent airflow in critical zones, the use of cracked compounding glassware, and uninvestigated pressure drops in cleanrooms during production. Additional violations included releasing raw materials for compounding before completing identity testing and moving materials through sterile areas in a manner that increased contamination risks. The FDA also noted that Apollo Care used bulk substances, specifically Semaglutide and Tirzepatide, that were not authorized for use by outsourcing facilities. These observations indicate a systemic failure to follow established safety and quality procedures. While this report is not a final determination of compliance, the firm is expected to provide a detailed response to the FDA outlining their corrective actions and plans to resolve these deficiencies to ensure the safety of their drug products.