FDA 483 - Amphastar Pharmaceuticals, Inc. - November 07, 2025

During an FDA inspection concluding on November 7, 2025, a firm was cited with several significant observations regarding its laboratory practices and data integrity. The main violations centered on a failure to disclose method validations and initial sample analyses in bioanalytical study reports, despite these being used to generate critical data. The inspection also revealed widespread non-adherence to established standard operating procedures and laboratory testing methods, including not reporting nonconformances, failing to include all method validation experiments in reports, and incomplete reporting of calibration and quality control data. Furthermore, the firm accepted quality control samples and calibration curves that did not meet established acceptance criteria, leading to potentially invalid method validation and study runs. Critically, the impact of significant interference observed in samples on assay precision and accuracy was not adequately assessed. Finally, discrepant source records, specifically regarding working standard solution lots, hindered the complete reconstruction of study data. These observations, documented on an FDA 483 form, indicate a need for the firm to implement robust corrective actions to ensure compliance with regulatory frameworks like the Federal Food, Drug and Cosmetic Act and maintain data reliability.