Megafine Pharma (P) Limited FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 24, 2017
Executive Summary
The FDA issued a warning letter to Megafine Pharma (P) Limited on February 24, 2017 citing adulteration. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Megafine Pharma (P) Limited's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Megafine Pharma (P) Limited.
Regulatory Context
an action plan to ensure the quality of your drugs, i.e., by notifying customers about adulterated material in your drug manufacturing process and recalling any adulterated drugs for U.S. distribution still within expiry;
a summary report of any corrective actions that you have implemented or plan to implement based on your consultant’s review of stability studies.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Megafine Pharma (P) Limited?
- The FDA issued a warning letter citing adulteration related to their products or manufacturing practices.
- Are Megafine Pharma (P) Limited products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have adulteration that may affect product safety.
- What should I do if I've used Megafine Pharma (P) Limited products?
- If you have used products from Megafine Pharma (P) Limited 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