FDA 483 - Xeridiem Medical Devices, Inc. - February 07, 2020

An FDA inspection of Westliem Medical Devices, Inc. in Tucson, AZ, revealed significant deficiencies in their quality system. Observations included inadequate documentation for validated processes, specifically regarding acceptance criteria and dimensional verification. Furthermore, the firm failed to implement written Medical Device Report (MDR) procedures, resulting in multiple delayed submissions for incidents involving serious injury and patient death.