Delta Laboratories Pty Ltd FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 19, 2017
Executive Summary
The FDA issued a warning letter to Delta Laboratories Pty Ltd on December 19, 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 Delta Laboratories Pty Ltd's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Delta Laboratories Pty Ltd.
Regulatory Context
A summary of the actions you have taken to comprehensively remediate your investigation process, and an improved procedure.
Data for(b)(4)batches successfully manufactured as part of prospective qualification studies, to demonstrate that these batches are stable over the shelf life.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Delta Laboratories Pty Ltd?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Delta Laboratories Pty 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 Delta Laboratories Pty Ltd products?
- If you have used products from Delta Laboratories Pty 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