The US Food and Drug Administration (FDA) has issued warning letters to multiple medical device manufacturers for violating current good manufacturing practices (CGMP) and marketing devices for unapproved uses.
Mectronic Medicale S.R.L. Cited for QSR and Unauthorized Claims
On August 5, 2025, the FDA published a warning letter addressed to Mectronic Medicale S.R.L., an Italian medical device manufacturer. The company was cited for:
- Nine violations of Quality System Regulation (QSR)
- Medical device reporting (MDR) violations
- Marketing devices for unapproved indications
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Mectronic manufactures several devices including CHELT, Ixyon XP, iLux Smart, iLux Plus, Doctor Tecar, Doctor Tecar Smart, and Doctor Tecar Plus, which are FDA-cleared for uses such as:
- Tissue heating
- Pain and muscle spasm relief
- Increasing local blood circulation
However, the company was found marketing these devices for unapproved conditions, including:
- Carpal Tunnel Syndrome
- Accelerated healing
- Boosting cellular metabolism
- Various musculoskeletal disorders such as lumbago and epicondylitis
According to the FDA, there is no clinical evidence supporting these expanded claims, and such unauthorized marketing may put patients at risk, including potential nerve damage, burns, and other injuries.
The company was also cited for failing to:
- Submit radiation safety product reports and annual reports for its laser-based devices
- Maintain proper design history files (DHF)
- Validate certain manufacturing processes
- Properly handle nonconforming products
Visgeneer, Inc. Cited for CGMP and Reporting Failures
Visgeneer, Inc., a Taiwan-based medical device manufacturer, also received a warning letter for CGMP violations related to its eBchek Blood Glucose Monitoring System.
The FDA identified the following issues:
- Lack of documentation for devices used in development and testing
- Missing production records and device specifications
- Failure to maintain proper complaint handling procedures
- Inadequate verification that products received from suppliers meet requirements
Visgeneer was also cited for failing to follow correction and removal procedures related to its eBuricacid/Uritouch blood uric acid monitoring system. The company did not report the product’s removal from the market within the required 10 working days, as outlined in 21 CFR Part 806.
The FDA had previously informed Visgeneer on October 30, 2023, that the eBuricacid device requires 510(k) clearance before it can be marketed in the United States. Despite this, the company only acted after the notification, instructing its distributor to remove the product from Amazon and other sales channels.
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Key Takeaways for Medical Device Manufacturers
These FDA enforcement actions underscore the importance of:
- Strict adherence to CGMP and QSR standards
- Proper device labeling and intended use marketing
- Timely regulatory reporting and compliance
Companies marketing medical devices in the US must ensure all products meet FDA premarket notification (510(k)) requirements and are manufactured in accordance with established quality systems to avoid enforcement actions and protect patient safety.
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