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

An FDA inspection of Siemens Healthcare Diagnostics, Inc. in East Walpole, MA, a medical device manufacturer, revealed multiple deficiencies in their quality system. Observations included inadequate verification of corrective and preventive actions, insufficient procedures for acceptance activities and documentation, unvalidated production software for reagent expiration dates, and undocumented equipment maintenance in controlled temperature rooms.