FDA 483 - Cardinal Health 414 LLC - July 01, 2025

Cardinal Health 414 LLC received an FDA Form 483 following an inspection conducted from June 23 to July 1, 2025. This document, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, outlines significant observations indicating potential issues with facility controls, production processes, and quality system implementation. Key observations include inadequate facility conditions impacting contamination prevention, such as chipped and flaking paint in critical cleanrooms (ISO-8 Gown Room, ISO-7 Production Room, ISO-7 Clean Room) and wear/staining in component storage and quality control areas. Furthermore, the inspection noted deficiencies in production and process controls, specifically the failure to adequately perform gloved fingertip personnel monitoring during sterile vial assembly operations in an ISO 5 Laminar Airflow Workbench, deviating from established procedures. A critical quality system observation was the firm's failure to implement previously proposed corrective actions from nonconformance investigations related to personnel monitoring issues, indicating a lack of effective problem resolution. Lastly, the company lacked adequate written procedures for the routine maintenance and qualification of laboratory equipment, exemplified by an overdue and insufficient qualification of a refrigerator storing temperature-sensitive materials. Cardinal Health 414 LLC is expected to provide a comprehensive response addressing these observations with detailed corrective and preventive actions to ensure compliance and product quality.