FDA 483 - Siemens Healthcare Diagnostics, Inc. - March 02, 2018

During an FDA inspection conducted from February 20 to March 2, 2018, Siemens Healthcare Diagnostics, Inc. in East Walpole, MA, received a Form FDA-483 detailing several observations regarding their quality system. The primary concerns included the inadequate verification of effectiveness for corrective and preventive actions (CAPA) in three specific instances. Furthermore, the firm's acceptance activity procedures were found to be deficient, with insufficient documentation for investigations into quality control deviations and a lack of Quality Control verification for the accuracy of linear bar code data on components prior to production release. The inspection also highlighted that software used in production, specifically for calculating reagent expiration dates, was not adequately validated for its intended purpose. Lastly, maintenance schedules for equipment, particularly preventive maintenance activities for controlled temperature room equipment used in product storage and processing, were not properly documented. These observations indicate potential non-compliance with quality system regulations outlined under the Federal Food, Drug, and Cosmetic Act. Siemens Healthcare Diagnostics, Inc. has committed to correcting these deficiencies to ensure regulatory adherence and product quality.