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

On March 21, 2025, the FDA issued a Warning Letter to EpiCare Acquisitions, LLC, following an inspection from November 12 to December 13, 2024, at their Lawrenceville, NJ facility. The inspection revealed that the firm's EpiCare-Zenith™ Family of Laser Systems are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(c) and (t)(2).

Key violations include: 1. **Design Validation (21 CFR 820.30(g)):** Failure to validate the design of the EpiCare-Zenith Laser Systems, lacking evidence of validation under defined operating conditions or on initial production units. The provided "Clinical Literature Review" did not utilize EpiCare-Zenith lasers. 2. **Complaint Files (21 CFR 820.198):** Failure to maintain complaint files and implement procedures for receiving, reviewing, and evaluating complaints. Complaints were not processed uniformly or timely, with many remaining open from 2022-2024. The firm failed to document investigations or reasons for not investigating, and did not evaluate complaints for Medical Device Reporting (MDR)