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.

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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