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FDA Subpoena

Getting a subpoena from the FDA – it’s one of the most frightening experiences for any company in the healthcare industry. As the regulatory body responsible for protecting public health, the FDA has massive enforcement powers to investigate violations of federal laws. If you or your company recieves an FDA subpoena, you need to understand what this means and how to respond appropriately.

I’m going to walk you through the most important things you need to know about FDA subpoenas – from what they are to how to respond strategically.

What’s an FDA Subpoena?

An FDA subpoena is basically a written demand for documents, tangible things, or testimony related to an FDA investigation. It requires you to provide specific materials or appear and answer questions from FDA investigators. Subpoenas are used by the FDA’s Office of Criminal Investigations and Office of Regulatory Affairs to gather evidence during investigations.

These investigations can involve many different issues – food safety problems, drug manufacturing violations, medical device defects, false labeling claims, data integrity concerns, consumer injuries. The list goes on and on. Most importantly, failure to comply with an FDA subpoena can result in serious legal penalties including fines or even jail time.

So you absolutely need to take these demands very seriously.

Who Gets FDA Subpoenas?

FDA subpoenas get sent to many different types of companies and individuals. Manufacturers and distributors of FDA-regulated products are common targets. Testing laboratories that analyze products or ingredients often recieve subpoenas too.

Healthcare facilities using medical devices, pharmacies, prescription drug wholesalers – they’re all potential recipients. Even physicians, consultants, attorneys, or other third parties involved with regulated firms can get subpoenaed. Basically anyone who has materials relevant to an FDA investigation could receive one of these demands.

What to Do When You Get an FDA Subpoena

If your organization gets hit with an FDA subpoena, there’s several critical steps you need to take immediately:

Notify Management NOW – Make sure your executives and legal counsel know about the subpoena right away. Time is extremely important here.

DON’T Destroy ANYTHING – Document retention and destruction policies must be halted immediately. This is absolutely crucial – destroying relevant materials can lead to obstruction of justice charges.

Assemble Your Response Team – You need to identify key people in legal, regulatory, IT, records managment, and relevant operations to coordinate your response. This isn’t a one-person job.

Review Everything Carefully – Figure out exactly what information and materials they’re requesting. Note all deadlines and specifications – the FDA is very particular about how they want things produced.

Decide on Compliance Strategy – In rare cases, there might be grounds to contest or limit the subpoena. But you need experienced FDA enforcement attorneys to advise on this – don’t try to make this decision yourself.

Start Gathering Materials – Use written litigation hold notices and coordinate with IT to search all electronic systems. Be extremely thorough in collecting everything listed in the subpoena.

Get an Attorney Immediately – Have counsel review the accuracy and completeness of your response. They can advise on formats, production procedures, and negotiating extensions if you need more time.

What Materials Does the FDA Want?

The types of information requested by FDA subpoenas vary tremendously depending on the investigation. But some common examples include:

Manufacturing Records – Master production schedules, batch records, equipment cleaning logs, calibration records, maintenance documentation, temperature charts. The FDA wants to see everything about how products are made.

Testing Data – Laboratory notebooks, test reports, raw data, validation studies, stability testing, certificates of analysis. Any data supporting product quality or safety claims.

Employee Records – Training records, standard operating procedures, manuals, attendance logs, exam results. They want to know if your people are properly trained.

Communications – Emails, letters, meeting minutes, notes, phone logs related to development, manufacturing, testing, marketing, or safety issues. Even text messages and instant messages can be subpoenaed.

Complaint Files – Records of adverse events, injuries, product quality issues reported by consumers. Previous FDA communications like warning letters or inspection reports.

Basically any document related to activities under FDA’s jurisdiction could potentially be requested.

How to Produce Records Properly

When producing materials to the FDA, proper formatting and organization is absolutely vital. The agency has very specific guidelines:

Electronic records should be provided in native formats on CD, DVD, or hard drives whenever possible. Include descriptive filenames and organized folders – don’t just dump everything in one place.

Paper documents need to be Bates stamped sequentially and produced in sturdy boxes with proper labels. Provide metadata and audit trails showing chain of custody and any record modifications.

Organize files in labeled folders by category, date, record type – make it easy for reviewers. Provide an index explaining what’s included and your file structure. Note any missing records and explain why they’re missing.

Use appropriate redactions to protect personnel records or trade secrets – but mark them clearly. Following FDA standards for information presentation is mandatory when responding to subpoenas.

What Happens After You Produce Records?

After you fulfill an FDA subpoena, several things might happen next:

Supplemental Requests – If the investigation reveals gaps, the FDA may issue additional subpoenas for more records. This is very common.

Employee Interviews – FDA agents may ask to interview personnel with knowledge about the materials you produced.

Facility Inspections – The FDA might schedule onsite inspections to tour facilities, review operations, or verify accuracy of records.

Continued Monitoring – They may continue monitoring your operations, reviewing records periodically, requiring regular reports.

Enforcement Actions – If violations are found, the FDA may issue warning letters, initiate product seizures, impose fines, or pursue criminal charges.

Complying with a subpoena isn’t necessarily the end – it often signals enhanced scrutiny and long-term oversight by the agency. Continued cooperation is extremely important to avoid stiffer penalties.

Why You Need Experienced Counsel

Receiving an FDA subpoena can be unsettling – there’s no doubt about that. But making missteps in your response could have devastating legal and financial consequences for your company.

Skilled FDA attorneys can help in many ways:

Strategic Advice – They can manage communications and negotiations with FDA officials related to the subpoena.

Thorough Compliance – They ensure completeness and accuracy in collecting responsive records – missing documents can be disastrous.

Gap Analysis – They identify potential inadequacies in your production response before the FDA does.

Written Responses – They craft required affidavits confirming record searches and materials provided.

Technical Compliance – They ensure all formatting protocols are met for submission to the FDA.

Interview Preparation – They represent and advise clients called for questioning by FDA agents.

By leveraging knowledgeable legal counsel, companies can demonstrate cooperation while protecting their interests. The FDA has broad investigative powers – you need someone who understands how to navigate this complex process.

The Bottom Line

FDA subpoenas are extremely serious matters that require immediate attention and strategic response. Don’t make the mistake of thinking these will just go away – they won’t. The FDA has massive resources and continues to seek expanded enforcement powers.

Most importantly, never ignore a subpoena or try to handle it without experienced counsel. The risks are simply too high – from criminal charges to business-ending penalties. With proper legal guidance and a thoughtful response strategy, you can navigate this challenging situation while minimizing damage to your company.