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.

Food Section

Why Would FDA’s Emergency Actions Stick Around After the Emergency is Over?

Why Would FDA’s Emergency Actions Stick Around After the Emergency is Over?

By Eric F. Greenberg, Attorney-at-law

While some of the Food and Drug Administration’s actions in response to COVID-19 have been traditional, many others have been simplifications of regulatory requirements, and those simplifications could be made permanent.

Here’s one type of activity that was traditional: The agency has been slapping down phony drug products. The moment the COVID-19 pandemic hit the scene, dietary supplement products claiming to cure or prevent the virus started to be offered for sale, and immediately FDA and the Federal Trade Commission started making a regular habit of issuing stern warnings to the makers of the products.

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