Helping Companies Stay Ready And Prepared

Businesses working in an FDA-regulated industry are subject to inspection by Food and Drug Administration (FDA) representatives. Depending on your company and the product or service you offer, there can be widely varying requirements that may need to be met. There can be many different reasons for an inspection, including consumer complaints, investigations of special topics and routine periodic inspections.

These inspections are not necessarily scheduled, and FDA representatives can demand access to your facility at any time to conduct them. There is a lot at stake in these situations, and many companies find great value in the assistance of a qualified attorney.

At the law firm of Eric F. Greenberg, P.C., we represent clients in a wide array of matters related to preparation for inspection and developing strategies to respond to FDA’s list of observations (Form FDA 483). No matter what stage of the process you may be in, you can feel confident in our firm’s ability to help you navigate these often complex processes.

Ongoing Compliance Is The Best Preparation

The old adage “an ounce of prevention is worth a pound of cure” is a good way to think about FDA compliance. There is no better way to prepare for an inspection than to govern your daily operations with a well-prepared and effectively executed compliance plan. If your company is in full regulatory compliance every day, you should have nothing to fear from an inspection. This is especially so with respect to foods, because of the extensive new requirements growing out of the Food Safety Modernization Act of 2011.

We work closely with our clients on their compliance plans and advise them on any areas where their plans do not meet regulations. We also work with clients who have recently been through an inspection and advise them of the steps that need to be taken in order to reduce the chances of more serious FDA enforcement actions.

Discuss Your Questions With A Lawyer

Contact our office in Chicago, Illinois, to schedule an appointment to speak with an attorney. You can reach us by phone at 312-977-4647 or contact us via email for 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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