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

Source: https://www.keypedia.com/records/warning_letter/epicare-acquisitions-llc/e9147315-88b3-4ce0-988f-1a05aab3e07f

> FDA WARNING_LETTER for Epicare Acquisitions, Llc on December 13, 2024. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Epicare Acquisitions, Llc
- Inspection Date: 2024-12-13
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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)

## Related Documents

- [483 - 2022-02-10](https://www.keypedia.com/records/483/epicare-acquisitions-llc/9db1fc4d-1714-4271-a68c-beef99877209)
- [483 - 2024-12-13](https://www.keypedia.com/records/483/epicare-acquisitions-llc/7d99ceaf-b8b4-43f4-9c5d-e13923ac4563)

## Related Officers

- [Bruce Wade](https://www.keypedia.com/people/bruce-wade/663a3335-effe-451e-ab64-0a8be987d758)
- [Islam Hafez](https://www.keypedia.com/people/islam-hafez/787a25bf-6573-4d3a-9772-91bdf4aebde4)
- [Sean Moynihan](https://www.keypedia.com/people/sean-moynihan/e1bfe2f8-5060-4589-9f0b-8773cad769f4)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)
- [Director of Compliance Branch](https://www.keypedia.com/people/gina-brackett/fa52f03a-8a7e-485e-8773-a1da3fa628d7)

Company: https://www.keypedia.com/companies/epicare-acquisitions-llc/00ff358c-1f18-422c-bdfb-b620f91674f6

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7