FDA 483 - Sage Products, LLC - July 11, 2025

During an FDA inspection conducted from July 7-11, 2025, at a drug product manufacturer identified as "FIRM NAME" in Cary, IL, two significant observations were made, indicating potential deviations from regulatory expectations under the Federal Food, Drug and Cosmetic Act. The primary issue identified was the inadequate sampling and testing of high-risk drug components, specifically "(b)(4)" and "(b)(4)", used in the manufacture of over-the-counter drug products. Between January 2024 and June 2025, an insufficient number of containers were sampled and tested from each lot of these critical components, raising concerns about the quality and safety of the final drug products. The second observation highlighted a failure to conduct thorough investigations into unexplained discrepancies. Specifically, repeated system suitability failures were noted during assay and impurity testing for commercial drug product batches. Instead of identifying and addressing the root cause of these failures, the firm reportedly retested samples and recorded passing results, indicating a lack of robust investigative processes. This FDA 483 document serves as a formal notification, requiring the firm to promptly address these conditions and practices by implementing comprehensive corrective and preventive actions to ensure full compliance with current Good Manufacturing Practices (cGMP) and prevent future recurrence of these issues.