Sound Advice In FDA Violation Matters

Unresolved violations of Food and Drug Administration (FDA) requirements can have a severely detrimental impact on your company. There is a good chance that your company will need to change the way it does things today, which could require considerable resources to implement across the enterprise. In addition, failure to correct violations can result in a product recall, seizure, injunction, detention, suspension of registration, Import Alerts, and, in rare instances, criminal prosecution of responsible individuals and companies.

If you have received an FDA Form 483 following an inspection indicating certain objectionable conditions or a Warning Letter regarding unresolved violations, you have a limited amount of time in which to respond. It is important that you have a capable advocate who understands the law and will offer sound advice with regard to what the violations mean and what steps need to be taken.

Helping Your Business Through A Complex Process

At the law firm of Eric F. Greenberg, P.C., our lawyers have represented clients in a broad range of FDA violation issues. We have a thorough understanding of FDA requirements and government enforcement of them. You can rely on us to provide you with the solutions you need to become compliant.

Talk To One Of Our Attorneys About Your FDA Violation Concerns

Discuss your compliance issues with a lawyer at the law firm of Eric F. Greenberg, P.C. We will explain our legal services and what we can do to help you. Call our Chicago, Illinois, office at 312-977-4647 or send us an email to schedule an initial consultation.

GRAS Goes to Congress

GRAS Goes to Congress

By Eric F. Greenberg, Attorney-at-law

Remember that whole business involving NGOs and other folks objecting to the legal system that allows companies to self-determine that their uses of substances are Generally Recognized As Safe (“GRAS”)? And remember how some groups had gone to court to get the system declared unlawful, but late last year the court ruled against them? Well, there’s a new chapter to this story. Now, some members of Congress have proposed a bill that would make changes to the law to address those very same objections.

The GRAS pathway to clearance of the use of substances in packaging and in food is crucially important, and this proposed law has the potential to make enormous changes in various legal obligations. For that reason, packagers should keep a close eye on this latest chapter in the ongoing debate over the policy issues surrounding the GRAS system.

In my view, addressing the complaints we’ve heard for years about the GRAS program required changes in the law, so at least the objectors are in the correct forum. There’s been so much criticism of the Food and Drug Administration lately, what with its slow reaction to the infant formula contamination problem, on top of its handling of issues relating to heavy metals in baby food and various complaints about its handling of COVID and other drug approvals, for some examples. But when it comes to the GRAS program, it’s always seemed that most of the objectors’ objections were better directed at Congress than at FDA.

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