FDA 483 - Turbare Manufacturing - May 27, 2026

Between April 20 and May 7, 2026, the FDA conducted an inspection of Turbare Manufacturing, an outsourcing facility located in Conway, Arkansas. The inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, identified several critical safety and quality control violations. Primarily, the facility’s Quality Control Unit failed to address persistent environmental issues, such as the use of dried and cracked monitoring plates caused by improper incubator humidity. Despite being aware of this issue for months, the firm failed to implement effective corrective measures. Furthermore, the inspection highlighted recurring fungal and bacterial contamination within cleanroom environments. The facility failed to perform adequate investigations into these incidents or conduct necessary dynamic airflow studies to ensure that sterile compounding areas were functioning correctly. Additional concerns included poor personnel hygiene practices leading to bacterial contamination and a failure to investigate high defect rates in drug batches during visual inspections. These findings suggest that drug products may have been prepared under unsanitary conditions that compromise sterility. Turbare Manufacturing is expected to review these observations and provide a formal response to the FDA outlining their planned corrective actions to bring the facility into compliance with safety standards.