Steiner Laboratories FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on June 21, 2017
Executive Summary
The FDA issued a warning letter to Steiner Laboratories on June 21, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Center for Devices and Radiological Health.
Detailed Analysis
False Claims and Regulatory Violations
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
Potential Health Risks
A description of any reasonably foreseeable risks or discomforts to the subject.
An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
Regulatory Context
This warning letter is part of the FDA's enforcement of federal regulations.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Steiner Laboratories?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Steiner Laboratories 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 Steiner Laboratories products?
- If you have used products from Steiner Laboratories 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