FDA 483 - Sure-Biochem Laboratories, LLC - March 08, 2024

During an inspection conducted from March 4-8, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Sure-Biochem Laboratories, LLC, a control testing laboratory located in Camden, NJ. The document outlines observations made by FDA investigators, highlighting significant deficiencies in the firm's compliance with regulatory standards.The primary observation noted was the failure to make records associated with drug product control readily available for inspection. Specifically, the FDA found that Sure-Biochem Laboratories did not provide a complete three-year retrospective raw data review as previously stated in their response to FDA Warning Letter #646619, dated October 25, 2023. Instead, only a limited 5% of client folders were reviewed.Furthermore, the inspection revealed that the company failed to conduct a comprehensive, independent assessment of its laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. This assessment was also a key recommendation from the aforementioned Warning Letter, which the company had indicated would be undertaken.These observations signify a lack of adequate control over drug product data and a failure to implement crucial corrective actions previously communicated to the FDA. Sure-Biochem Laboratories is required to address these findings to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act and ensure the integrity of its testing operations.