What did the FDA find wrong with CHUNGDO PHARM. CO. LTD.?

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

Are CHUNGDO PHARM. CO. 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 CHUNGDO PHARM. CO. LTD. products?

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

CHUNGDO PHARM. CO. LTD. FDA Warning (2017)

Name: CHUNGDO PHARM. CO. LTD. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:20.029420

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 21, 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 CHUNGDO PHARM. CO. LTD. on July 21, 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 CHUNGDO PHARM. CO. LTD.'s operations or product claims.

Potential Health Risks

Shon KimPresidentChungDo Pharm. Co.LTD.202 HI-TECH VENTURE TOWN198-53 HUPEONG-DONGCHUNCHEONJUL z l 2onKorea, Republic of (South) 200-160

Donald J. St. PierreActing Deputy Director forPatient Safety and Product QualityOffice of In Vitro Diagnosticsand Radiological HealthCenter for Devices and Radiological Health

Regulatory Context

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated July 30, 2013. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

CHUNGDO PHARM. CO. LTD. FDA Warning Letter

Frequently Asked Questions

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

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.