FDA 483 - Epicare Acquisitions, Llc - December 13, 2024

Epicare Acquisitions, Llc in Lawrenceville, NJ, a manufacturer of EpiCare ZenithTM Laser Systems, was cited with 10 observations during an FDA inspection. The inspection revealed significant deficiencies in design validation, complaint handling, corrective and preventive actions, device history records, device master records, training, and document control. Additionally, the firm failed to register its devices in the UDI database and properly label them with UDIs, indicating systemic quality system failures.