FDA Subpoena

Overview

Receiving a subpoena from the U.S. Food and Drug Administration (FDA) can be an intimidating and stressful experience. As the regulatory body responsible for protecting public health by overseeing food, drugs, medical devices, cosmetics and more, the FDA has broad authority to investigate violations of federal laws and regulations. If you or your company is the recipient of an FDA subpoena, it is important to understand what it means and how to respond appropriately. This guide covers the key things you need to know.

What is an FDA Subpoena?

An FDA subpoena is a written demand for documents, tangible things, or testimony related to an FDA investigation. It requires the recipient to provide the specified materials or appear and answer questions. Subpoenas are used by the FDA’s Office of Criminal Investigations and Office of Regulatory Affairs to gather evidence during investigations into regulated products or entities. These may include investigations into:

• Food, drug, medical device or other product safety issues
• False or misleading labeling claims
• Manufacturing problems
• Data integrity concerns
• Consumer complaints or injuries
• Suspected criminal violations of FDA regulations

Failure to comply with an FDA subpoena can result in legal penalties including fines or jail time. So it is essential to take these demands seriously.

Who Can Receive an FDA Subpoena?

FDA subpoenas are often sent to:

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Legal Scenario: What Would You Do?

Scenario

Federal agents execute a search warrant at your medical practice, seizing patient records and prescription logs.

Can they take patient records without patient consent?

Attorney's Answer

A valid federal search warrant overrides HIPAA privacy protections. However, the warrant must be properly scoped. An attorney can challenge overly broad warrants and move to suppress improperly seized evidence.

This is general information only. Contact us for advice specific to your situation.

• Manufacturers and distributors of FDA-regulated products
• Testing laboratories contracted to analyze products, ingredients, environments, etc.
• Healthcare facilities that use medical devices
• Pharmacies and prescription drug wholesalers
• Physicians and other healthcare providers
• Consultants, attorneys, or other third parties involved with regulated firms

Essentially anyone that possesses materials relevant to an FDA investigation could receive a subpoena demanding those materials.

What Should You Do if You Receive an FDA Subpoena?