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# FDA Warns Technological Medical
- URL: https://www.fdaweb.com/fda-warns-technological-medical/
- Published: 2025-10-07T12:00:00.000Z
- Updated: 2026-09-14T15:23:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159995

A 4/9-4/21/2025 FDA inspection at Technological Medical Advancements in West Palm Beach, FL, identified multiple violations in the firm’s manufacturing of two unapproved laser systems. A 9/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/technological-medical-advancements-llc-712715-09262025?ref=fdaweb.com) says specific Quality System Regulation violations were:

- failure to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
- failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to maintain complaint files;
- failure to adequately establish and maintain procedures for corrective and preventive action;
- failure to establish and maintain adequate procedures for quality audits; and
- failure to establish procedures to control product that does not conform to specified requirements.

FDA says the company’s responses to the inspection observations were inadequate.

The letter also lists unique device identifier regulation violations.

Technological Medical Advancement was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.