> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mectronic Medicale Multiple Violations
- URL: https://www.fdaweb.com/mectronic-medicale-multiple-violations/
- Published: 2025-08-05T12:00:00.000Z
- Updated: 2026-09-14T15:18:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159626

A 2/24-2/27 FDA inspection at the Mectronic Medicale S.R.L. facility in Bergamo, Italy, identified Quality System, Medical Device Reporting, and other violations in the firm’s illegal manufacturing of adulterated and misbranded laser medical devices. A just-released 6/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mectronic-medicale-srl-707997-06272025?ref=fdaweb.com) says the firm manufactures seven devices. The letter says Quality System Regulation violations were:

- failure to establish and maintain a device history file for each type of device;
- failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures;
- failure to establish and maintain procedures to control product that does not conform to specified requirements;
- failure to establish and maintain procedure acceptance activities;
- failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements;
- failure to maintain device history records; and
- failure to establish procedures for quality audits and to conduct such audits

The inspection found that the firm failed to develop, maintain, and implement written Medical Device Reporting procedures. Its devices are adulterated, FDA says, because it does not have an approved PMA or IDE in effect for them. The products are misbranded because Mectronic did not notify FDA of its intent to introduce the devices into commercial distribution intended for a use different from the intended use of a legally marketed device without submitting a premarket notification to FDA.

The letter says Mectronic also failed to comply with reporting requirements applicable to electronic products under the radiological health regulations, including failure to submit a radiation safety product report followed by annual reports, and failure to have labeling comply with regulations.

Mectronic was told 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.