X-Ray Systems, Inc. – FDA 483, Mar 4, 2022

X-Cel X-Ray Corp in Crystal Lake, IL, received a Form FDA 483 with five observations during an inspection of their manufacturing facility for Class II medical devices. The observations highlight significant deficiencies in their quality system, including issues with device history records, process validation, design output documentation, design verification, and device master record maintenance. Several of these issues, particularly concerning the device master record and process validation, were noted as repeat observations from prior inspections.