FDA 483 - SRI Healthcare LLC - January 12, 2023

During an inspection, SRI Healthcare LLC, a sterilizer/repackager/relabeler in Chattanooga, TN, was cited for failing to adequately establish and control production processes. Specifically, the firm did not properly document sterilizer cycle deviations, sterilizer checks, and monthly maintenance activities for washers and sterilizers. This indicates significant deficiencies in their quality system's process control and documentation practices.