FDA 483 - STAQ Pharma of Ohio, LLC - August 19, 2026

STAQ Pharma of Ohio, LLC, an outsourcing facility in Columbus, Ohio, underwent an FDA inspection from August 10 to August 19, 2026. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, identified several significant quality control and safety violations regarding the production of sterile injectable drug products. Key issues involved inadequate visual inspection protocols for syringes. The FDA found that the facility"s qualification process did not require staff to distinguish between minor and critical defects, and training materials failed to include various known contaminants such as cloudiness or particles. Furthermore, the firm did not sufficiently track defect trends to identify systemic performance issues. Investigators also observed that sterility validation procedures, known as media fills, did not accurately simulate actual production conditions. These tests failed to account for operator fatigue during long shifts or different syringe sizes used in regular manufacturing. Additionally, the facility did not record specific light intensity measurements during inspections and failed to qualify staff on new protective gowning components before implementation. To resolve these observations, STAQ Pharma is required to provide a formal response to the FDA. This response must detail the corrective actions the firm has taken or plans to implement to ensure their manufacturing processes meet safety and quality standards.