So your probably staring at this massive document demand from the FDA and your hands are literaly shaking. Maybe your drug manufacturing facility just got inspected and they found “issues.” Maybe someone reported adverse events from your dietary supplement. Or maybe your medical device has been linked to patient injuries and now there coming after you. Look, we get it. Your TERRIFIED. And honestly? You should be! Because FDA violations can mean criminal prosecution with up to 10 years in prison and fines reaching MILLIONS!
What Happens When FDA Investigates Your Company?
Let me tell you exactly what your facing when the FDA targets your business with a Civil Investigative Demand. The FDA has incredibly broad powers under the Federal Food, Drug, and Cosmetic Act to demand documents, inspect facilities, and gather evidence of violations – all without needing court approval first.
When FDA issues a CID, there not just looking at one issue. There gonna dig through everything: your manufacturing processes, quality control records, clinical trial data, adverse event reports, marketing materials, communications with healthcare providers, financial relationships with doctors, import/export documentation. Its a complete colonoscopy of your entire operation!
The really scary part? FDA investigations often run parallel with criminal investigations by there Office of Criminal Investigations (OCI). So while your responding to what seems like a “civil” investigation, your actualy providing evidence that could be used to prosecute you criminaly. We’ve seen executives go from thinking they were dealing with regulatory issues to being arrested by federal agents. Its absolutely INSANE how quickly things escalate!
How Bad Can FDA Penalties Really Get?
Want to know the nightmare your facing? Let us break down the numbers that’ll make your stomach drop. Civil monetary penalties start at $10,000 to $20,000 per violation, but FDA routinely pursues multiple violations simultaneously. We’ve seen single warning letters cite 50+ violations – do the math!
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(212) 300-5196But wait, it gets worse. If someone dies from your product? Criminal fines jump to $500,000 for corporations and $250,000 for individuals, plus up to 10 years in federal prison. And here’s what’s especialy terrifying – FDA uses the “responsible corporate officer doctrine” meaning executives can be held personaly liable even if they didn’t know about the violations!
Consent decrees are another nightmare. These court-enforced agreements can shut down your operations until you fix everything to FDA’s satisfaction. We had a client whose facility was shut down for 18 months under a consent decree – they lost $50 million in revenue and never recovered. The company that employed 200 people doesn’t exist anymore.
What Triggers an FDA Investigation?
Your probably wondering “Why did FDA target me?” Let us tell you the most common triggers that put companies in FDA’s crosshairs.
Todd Spodek
Lead Attorney & Founder
Featured on Netflix's "Inventing Anna," Todd Spodek brings decades of high-stakes criminal defense experience. His aggressive approach has secured dismissals and acquittals in cases others deemed unwinnable.
Adverse event reports are huge – even a handful of serious adverse events can trigger a full investigation. And here’s the dirty secret: competitors often encourage patients to file adverse event reports about your products to trigger investigations. We’ve seen it happen dozens of times. Whistleblower complaints from employees are massive triggers, especialy since they can get rewards for reporting violations.
Your pharmaceutical company just received a Civil Investigative Demand from the FDA requesting five years of manufacturing records, quality control reports, and internal communications about your top-selling generic blood pressure medication. The CID arrived three weeks after an FDA inspector noted deviations from Current Good Manufacturing Practice regulations during a routine facility inspection.
How long do we have to respond to this FDA Civil Investigative Demand, and can we push back on the scope of what they're requesting?
Under 21 U.S.C. § 346, the FDA typically sets a response deadline of 30 to 45 days in the CID itself, but our first move would be to contact the issuing attorney and negotiate a reasonable extension and narrowed scope — this is standard practice and the FDA expects it. We would file formal objections or a petition to modify or set aside the CID under the applicable regulations if the requests are overly broad or unduly burdensome, particularly those sweeping demands for all internal communications. It is critical that you implement a litigation hold immediately to preserve every document potentially responsive to this CID, because spoliation of evidence in an FDA investigation can escalate a civil matter into criminal referral under 18 U.S.C. § 1519. We have handled dozens of these demands and in most cases we can significantly narrow the production while maintaining full compliance with the law.
This is general information only. Contact us for advice specific to your situation.
Failed inspections obviously trigger deeper investigations. But here’s what’s unfair – even if you pass an inspection, if the inspector doesn’t like something, they can still refer you for investigation. Import alerts for foreign manufacturers often lead to CIDs. Off-label promotion allegations are FDA’s favorite – they love going after companies for truthful speech about there own products!
