Is Bertrand Bulls Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 31, 2017
Executive Summary
The FDA issued a warning letter to Bertrand Bulls on March 31, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Bertrand Bulls's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Bertrand Bulls.
Regulatory Context
The Food and Drug Administration has completed an evaluation of Bertrand Bulls corrective actions in response to our Warning Letter (CMS case #: 490864) on March 8, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Miguel A. HernandezDirector, Compliance BranchKansas City District
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Bertrand Bulls?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Bertrand Bulls 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 Bertrand Bulls products?
- If you have used products from Bertrand Bulls 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