FDA 483 - Tech Medical Services, Inc - September 19, 2023

Tech Medical Services, Inc. in Nixa, MO, a repackager/relabeler of medical devices, received a Form FDA 483 with five observations during an inspection from September 18-19, 2023. The observations primarily concern deficiencies in the firm's quality system, including inadequate procedures for supplier control, finished device acceptance, employee training, management review, and quality audits. These issues indicate a lack of established and maintained quality system processes, specifically impacting Class II sterile probe covers.