FDA 483 - Catalent Indiana, LLC - April 24, 2026

Between April 13 and April 24, 2026, the FDA inspected the Catalent Indiana LLC facility in Bloomington, Indiana, a sterile drug manufacturer. The inspection resulted in an FDA Form 483 identifying eight primary areas of concern regarding the site"s quality systems and manufacturing controls. The most critical violations involved inadequate investigations into recurring contamination. Specifically, mammalian hair was repeatedly found in finished sterile products, and multiple roof leaks caused water to enter cleanrooms, forcing the cancellation of production simulations. In both cases, the firm failed to identify root causes or implement effective corrective measures. Additionally, the FDA found that the visual inspection program was not properly qualified to detect defects and often misclassified foreign contaminants. Other significant issues included insufficient validation of aseptic processes, poor airflow studies, and a lack of rigorous environmental monitoring during high-risk tasks. The Quality Unit also failed to provide adequate trending analysis for decontamination programs and lacked detailed instructions for identifying product defects. These observations were made under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, which requires drugs to be manufactured under sanitary conditions to ensure safety. While the Form 483 is not a final legal determination, the company is required to submit a formal response to the FDA. This response must detail specific corrective and preventative actions taken to address the identified deficiencies and prevent their recurrence.