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# Multiple Violations at EpiCare Acquisitions
- URL: https://www.fdaweb.com/multiple-violations-at-epicare-acquisitions/
- Published: 2025-04-08T12:00:00.000Z
- Updated: 2026-09-14T14:57:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158970

An 11/12-12/13/2024 FDA inspection at EpiCare Acquisitions in Lawrenceville, NJ, found Quality System Regulation and other violations in the firm’s manufacturing of the EpiCare-Zenith family of laser systems. A just-released 3/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/epicare-acquisitions-llc-702493-03212025?ref=fdaweb.com) says the specific violations were:

- failure to establish and maintain procedures for validating the device design;
- failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failure to establish and maintain procedures for implementing corrective and preventive action;
- failure to maintain device history records;
- failure to maintain device master records;
- failure to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities;
- failure to have compliant electronic product radiation control labeling;
- failure to have complaint Medical Device Reporting procedures;
- failure to have compliant labeling; and
- failure to submit required information to GUDID (Global Unique Device Identification Database).

The letter says the firm’s responses to the inspection observations were inadequate or their adequacy could not be determined. EpiCare was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.