Lumis Global Pharmaceuticals Co. Ltd. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 02, 2017
Executive Summary
The FDA issued a warning letter to Lumis Global Pharmaceuticals Co. Ltd. on March 02, 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 Lumis Global Pharmaceuticals Co. Ltd.'s operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Lumis Global Pharmaceuticals Co. Ltd..
Regulatory Context
Provide a plan to establish, document, and implement an effective system for managing quality. Include written procedures for CGMP-related activities and the roles of personnel responsible for oversight.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Lumis Global Pharmaceuticals Co. Ltd.?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Lumis Global Pharmaceuticals 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 Lumis Global Pharmaceuticals Co. Ltd. products?
- If you have used products from Lumis Global Pharmaceuticals 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