What did the FDA find wrong with UVLRX Therapeutics Inc?

The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.

Are UVLRX Therapeutics Inc products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.

What should I do if I've used UVLRX Therapeutics Inc products?

If you have used products from UVLRX Therapeutics Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

UVLRX Therapeutics Inc FDA Warning (2017)

Name: UVLRX Therapeutics Inc FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:22.301397

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 25, 2017

MODERATE SEVERITY Center for Devices and Radiological Health 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to UVLRX Therapeutics Inc on September 25, 2017 citing labeling violations. The letter was issued by Center for Devices and Radiological Health.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

A preventive action plan demonstrating how you will ensure that all of anticipated and unanticipated adverse device effects will be adequately received and documented.

A preventive plan to ensure that for future studies all shipment and disposition of devices will be adequately monitored and documented.

A preventive action plan to ensure that for future studies all participating investigators will obtain informed consent under part 50 and documents it, unless documentation is waived by an IRB under 21 CFR 56.109(c). In addition, ensure that the informed consent document will contain all the required basic elements.

Potential Health Risks

Consumers should be aware of potential risks associated with products from UVLRX Therapeutics Inc.

Regulatory Context

Timeline for the implementation of the corrective actions, finalized SOPs, and follow-up.

Key Entities Identified

21 CFR 56.109

Frequently Asked Questions

What did the FDA find wrong with UVLRX Therapeutics Inc?: The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
Are UVLRX Therapeutics Inc products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
What should I do if I've used UVLRX Therapeutics Inc products?: If you have used products from UVLRX Therapeutics Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.