What did the FDA find wrong with WalkMed, LLC?

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

Are WalkMed, LLC products safe to use?

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

What should I do if I've used WalkMed, LLC products?

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

Is WalkMed, LLC Safe? FDA Warning Letter Review (2017)

Name: Is WalkMed, LLC Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:18.216077

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 01, 2017

MODERATE SEVERITY 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 WalkMed, LLC on May 01, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in WalkMed, LLC's operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from WalkMed, LLC.

Regulatory Context

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-01 WL, dated November 2, 2015. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter pertaining to your Triton and Triton FP infusion pumps and associated tubing sets. We acknowledge receipt of your written response dated March 7, 2017 which states that WalkMed Infusion has sold the Triton Infusion pump 510(k) to a new firm who will be responsible for the products going forward. Your written commitments also state that WalkMed Infusion will no longer be manufacturing any medical devices or engaged in activities under the purview of the FDA Future FDA inspections and regulatory activities will further verify

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority should your firm elect to restart operations. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

WalkMed LLC FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with WalkMed, LLC?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are WalkMed, LLC products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
What should I do if I've used WalkMed, LLC products?: If you have used products from WalkMed, LLC 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.