FDA 483 - Serum Institute of India Pvt. Ltd. - July 02, 2024

During inspections conducted from June 24-29, 2024, and July 1-2, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Serum Institute of India Pvt. Limited Manjari Site, a vaccine manufacturer. This document outlines observations indicating potential deviations from regulatory manufacturing standards. Significant issues include inadequate requalification of sterilization equipment for COVID vaccine syringe and vial filling lines. This involved repeated failures in sterilization acceptance criteria and insufficient investigation into positive results from 2022 and 2023, raising concerns about the equipment's ability to consistently sterilize critical areas. The FDA also noted a lack of sufficient data to assure adequate cleaning processes to prevent cross-contamination between different vaccine products using shared equipment. Furthermore, a crucial validation study for equipment performance remains incomplete, despite a commitment made during a previous 2022 inspection. Other observations involved deficiencies in qualifying reference standards, including missing data and a failure to investigate invalid test results. Lastly, the firm did not thoroughly investigate a critical defect found in a batch or implement effective corrective and preventive actions. Serum Institute of India Pvt. Limited is expected to provide a comprehensive response addressing these observations to ensure compliance with regulatory requirements and maintain product quality.