FDA 483 - Lifewatch Services Inc - April 16, 2019

Lifewatch Services Inc, a repacker/relabeler of Class 2 Medical Device Kits in Rosemont, IL, was cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for corrective and preventive actions and inadequate investigation of device malfunction complaints. Furthermore, the firm failed to properly establish procedures for receiving, reviewing, and evaluating complaints, including Medical Device Reporting evaluations.