What did the FDA find wrong with Navinta, LLC?

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

Are Navinta, 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 Navinta, LLC products?

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

Is Navinta, LLC Safe? FDA Warning Letter Review (2018)

Name: Is Navinta, LLC Safe? FDA Warning Letter Review (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:26.357059

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 05, 2018

MODERATE SEVERITY 2018

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 Navinta, LLC on March 05, 2018 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 Navinta, LLC's operations or product claims.

Potential Health Risks

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

Regulatory Context

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated September 26, 2016 (Ref: 16‐NWJ‐16). Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its regulations or with other relevant legal authorities. The Agency expects you 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.

LaShanda Long, M.S.Branch ChiefPostmarketing Safety BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug AdministrationBuilding 51, Room 535610903 New Hampshire AvenueSilver Spring, MD 20993‐0002

Key Entities Identified

Navinta LLC FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Navinta, LLC?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Navinta, 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 Navinta, LLC products?: If you have used products from Navinta, 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.