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Unicord Public Company Ltd. FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 26, 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 Unicord Public Company Ltd. on July 26, 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 Unicord Public Company Ltd.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Unicord Public Company Ltd..

Regulatory Context

Sutin Sawaengsin, Factory Division ManagerUnicord Public Company Ltd.56/5 Moo 3, Baansrimuang Road, ThasaiMuang, Samut Sakhon 74000Thailand

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions following issuance of our Warning Letter #488033, issued February 5, 2016. Based on our evaluation, it appears 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 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

Unicord Public Company Ltd. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Unicord Public Company Ltd.?
The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Unicord Public Company Ltd. 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 Unicord Public Company Ltd. products?
If you have used products from Unicord Public Company 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
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.