Is Seindni Co., Ltd. Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 05, 2017
Executive Summary
The FDA issued a warning letter to Seindni Co., Ltd. on December 05, 2017 citing cgmp violations. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Seindni Co., Ltd.'s operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Seindni Co., Ltd..
Regulatory Context
Written procedures establishing your supplier and contractor qualification, selection, and oversight program, including procedures to ensure compliance with drug CGMP at all stages of manufacturing, processing, packing, or holding.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Seindni Co., Ltd.?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Seindni Co., Ltd. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
- What should I do if I've used Seindni Co., Ltd. products?
- If you have used products from Seindni 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