FDA 483 - AURORIUM LLC - March 06, 2026

From March 2 to March 6, 2026, the Food and Drug Administration (FDA) inspected Aurorium LLC, an active pharmaceutical ingredient (API) manufacturer located in Midlothian, Texas. The inspection revealed several critical violations of the Federal Food, Drug, and Cosmetic Act regarding the facility"s quality systems and physical maintenance. Major issues identified include a failure to maintain the manufacturing facility, evidenced by water leaks, significant corrosion, and deteriorating walls and floors. In one instance, clear tape was used as a makeshift repair on production equipment. The company also failed to investigate multiple test results that fell outside of safety limits for endotoxins and lacked a process for assessing the impact on product quality. Further oversight failures were noted within the Quality Unit, including incomplete or delayed corrective actions, a lack of controlled manufacturing and laboratory forms, and the absence of a required annual product quality review for 2024. Additionally, the firm could not provide complete test results for the water used in production and the laboratory. While this document represents preliminary observations and not a final agency determination, Aurorium LLC is expected to provide a detailed response to the FDA. The company must implement corrective actions to address facility repairs, formalize its quality oversight procedures, and ensure all manufacturing and testing deviations are thoroughly investigated and documented.