RC Outsourcing, LLC – FDA 483, Sep 3, 2026

From August 24 to September 3, 2026, the FDA inspected RC Outsourcing, LLC, a specialized drug compounding facility. The inspection identified several critical safety and quality control violations that could compromise product sterility. Key issues included inadequate validation of sterile environments, specifically flawed airflow visualization studies that lacked documentation and failed to simulate actual production conditions. Furthermore, the company’s testing processes did not account for worst-case scenarios, such as shift changes and line clearances. Investigators also observed poor aseptic techniques, noting that staff moved between cleanrooms and less-controlled areas without properly changing protective gear. Environmental monitoring was found to be deficient, and the firm failed to adequately investigate sterility test failures, even releasing batches manufactured on the same day as those that failed. Structural issues, such as shared pathways for sterile and non-sterile materials and obstructed air vents, were also noted. Additionally, the facility lacked proper staff training programs and failed to include required storage temperature instructions on product labels. These observations were issued under the Food, Drug, and Cosmetic Act as a formal notification of conditions that may lead to contaminated or unsafe products. RC Outsourcing, LLC is required to review these findings and should submit a formal response to the FDA detailing their corrective actions or providing justification for their current practices.