Is Neo Vision Co Ltd Safe? FDA Warning Letter Review (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 20, 2018
Executive Summary
The FDA issued a warning letter to Neo Vision Co Ltd on February 20, 2018 citing labeling violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Neo Vision Co Ltd's operations or product claims.
Potential Health Risks
CAPT Raquel Peat, PhD, MPHDirectorDivision of Premarket and Labeling ComplianceOffice of ComplianceCenter for Devices and Radiological Health
Regulatory Context
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our letter (CMS# 506797) dated September 14, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
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. 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
Frequently Asked Questions
- What did the FDA find wrong with Neo Vision Co Ltd?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Neo Vision Co Ltd 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 Neo Vision Co Ltd products?
- If you have used products from Neo Vision Co Ltd 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