FDA 483 - Epicare Acquisitions, Llc - February 10, 2022

Epicare Acquisitions, Llc in Lawrenceville, NJ, was inspected by the FDA, resulting in three observations. The inspection revealed significant deficiencies in device history records, including incomplete testing and review, as well as inadequate documentation of design verification results for laser devices. Additionally, the firm lacked established procedures for identifying training needs and documenting personnel training.