Trackx Technology Inc – FDA 483, Aug 14, 2024

An FDA Form 483 was issued to Trackx Technology Inc. following an inspection conducted from August 6 to August 14, 2024. The inspection revealed several deviations from established quality system requirements for manufacturers. Key observations included deficiencies in quality audit procedures. Specifically, the firm's internal auditors conducted audits of areas they were responsible for, contrary to their own Quality Manual, and internal audits in 2022 were performed by an untrained lead auditor. Another significant issue involved the inadequate control of nonconforming products. Materials not meeting specifications, including returned customer products or uninspected finished goods in the warehouse, lacked clear identification or labeling, failing to prevent their unintended use or shipment. Finally, procedures for acceptance activities, particularly for Return Merchandise Authorization (RMA), were not adequately followed. RMA numbers were not consistently recorded in the log, and required RMA forms were not attached to corresponding materials in the quarantine area. This document serves as an official notice of inspectional observations and is not a final determination of compliance. Trackx Technology Inc. is responsible for addressing these issues by implementing corrective actions and ensuring adherence to all applicable quality system regulations. The company is expected to conduct internal self-audits to identify and rectify all violations.