FDA 483 - Encore Medical, LP - October 28, 2021

Encore Medical, LP in Austin, TX, was inspected and received a Form FDA 483 with two observations. The inspection revealed inadequate documentation of corrective and preventive actions, including issues with root cause investigations and late Medical Device Reports. Additionally, the firm failed to adequately review, evaluate, and investigate customer complaints, leading to lost or unevaluated returned components and a lack of subsequent corrective actions.