FDA 483 - Encore Medical, LP - December 08, 2023

Encore Medical, LP, a medical device manufacturer in Austin, TX, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system processes, including failure to report a recall, inadequate acceptance activities, and systemic failures in corrective and preventive action procedures and risk analysis. These issues indicate a severe lack of control over manufacturing and quality processes, contributing to recurring product mix-ups and malfunctions.