FDA 483 - Delasco Inc - January 14, 2025

Delasco, LLC, a medical device manufacturer and initial importer/distributor in Plano, TX, was inspected by the FDA. The inspection revealed significant deficiencies in its quality system, specifically regarding the lack of established and implemented procedures for Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), and finished device acceptance activities. These findings indicate a serious lack of fundamental quality system controls for medical devices.