FDA EIR - Sterigenics US LLC - April 09, 2019

An FDA surveillance inspection of Sterigenics US LLC in San Diego, CA, took place from April 8-9, 2019. The inspection, conducted under Compliance Programs 7356.002 for Drug Manufacturing, focused on the company's quality, production, and packaging/labeling systems related to radiation sterilization services. Sterigenics provides contract sterilization for medical devices and R&D pharmaceutical samples, notably a specific drug container closure system used in an approved drug application. The company clarified it does not sterilize commercial drug products, even pulling its drug establishment registration to confirm this during the inspection. Crucially, the inspection identified no significant GMP or Quality System deficiencies, and no Form FDA 483 (Inspectional Observations) was issued. However, one procedural enhancement was verbally discussed with management. It was noted that the firm lacked a comprehensive written general maintenance procedure that adequately directed employees to detailed maintenance work instructions. Additionally, the existing Measurement and Calibration SOP did not explicitly link to its corresponding detailed work instructions. To address this, Sterigenics Ys Quality Assurance Manager committed to drafting and implementing a general maintenance procedure within one month, demonstrating a clear action to improve documentation and procedural clarity.