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FDA inspectors showed up at your facility yesterday. Or maybe it was last week. You let them in - of course you let them in, you're running a legitimate business, you have nothing to hide. They walked the production floor, asked questions about your processes, took photos, requested documents. At the end they handed you a Form 483 with a list of observations. They were professional. They seemed friendly enough.
That wasn't a routine inspection.
The FDA doesn't show up at supplement companies randomly. They show up because something triggered their attention - a complaint, a data analytics flag, an adverse event report, an internet surveillance hit. Your business was on a list before they walked through your door. What happens next depends entirely on how you respond in the next 15 days. And here's what you need to understand right now: under something called the Park Doctrine, you as the business owner can go to federal prison for violations you didn't personally know about and weren't personally involved in.
Welcome to Spodek Law Group. We handle FDA enforcement defense for dietary supplement companies facing inspections, warning letters, and criminal investigations. If you just got a Form 483, if you've received a warning letter, or if you suspect the investigation has escalated to the Office of Criminal Investigations - this article explains exactly what you're facing.
That Inspection Wasn't Random
The FDA has its own law enforcement arm. The Office of Criminal Investigations employs federal agents with badges and arrest authority. These aren't the compliance inspectors who showed up at your facility. But here's what actualy happens: the compliance inspection feeds information to OCI. The friendly inspector who walked your floor may be building a case for criminal investigators you haven't met yet.
The USPlabs case shows what's possible. In 2020, a federal court in Texas sentenced the company's CEO, Jacobo Geissler, to 60 months in federal prison. The president, Jonathan Doyle, received 24 months. A vice president from the manufacturing partner got 41 months. The companies paid $10.7 million in criminal forfeiture. All from selling supplements - OxyElite Pro and Jack3d - that the FDA determined contained adulterated ingredients. These weren't street dealers. They were running what looked like a legitimate supplement company.
The escalation ladder works like this:
Form 483 observations (you have 15 business days to respond)
Warning Letter (posted publicly on FDA's website, announces potential legal action)
Injunction or product seizure
Criminal referral to the Department of Justice
Each step up is harder to stop. Once your getting a Warning Letter, your already in trouble. Once OCI gets involved, your facing potential criminal prosecution. The ladder only goes one direction.
Quality Formulation Laboratories in New Jersey learned this. The FDA found what the DOJ called "egregious sanitation and manufacturing problems." They got a consent decree - basicly a court order to clean up there act. Instead of complying, they continued distributing product. The owner and managers were sentenced for criminal contempt. The DOJ's exact words: "The defendants thumbed their nose at [the court order] and continued distributing product."
And here's the part that multiplies the damage: an FDA inspection can trigger enforcement from multiple agencies simultaneously. The FTC can use your FDA findings to pursue false advertising claims. State regulators can open their own investigations. The DOJ can bring federal charges while state attorneys general pile on. What starts as Form 483 observations about record-keeping can spiral into a multi-agency enforcement action with criminal, civil, and administrative consequences running in paralel.
The Park Doctrine: Prison Without Knowing
Most people assume you need to know about a violation to face criminal liability for it. You need intent. You need personal involvement. That's how criminal law normaly works.
The "Responsible Corporate Officer" doctrine - named after the Supreme Court case United States v. Park - allows criminal prosecution of company executives for FDCA violations even when they had no personal knowledge of the misconduct. The government only needs to prove three things: (1) you held a position of authority in the company, (2) you had the ability to prevent or correct the violation, and (3) you failed to do so. Knowledge is not an element. Intent is not an element. You can go to prison for something your employees did that you never knew about.
Austin and Peter DeCoster, executives at an egg distribution company, received three months in federal prison for violations they had no personal knowledge of. They weren't accused of personally contaminating eggs. They were accused of being responsible for a company that did. The Purdue Pharma executives paid a combined $34.5 million and were excluded from federal healthcare programs - not for personally misleading anyone, but for being responsible corporate officers of a company that did.
If your the owner, your the target.
The FDCA penalty structure makes the risk even more severe:
First offense without intent to defraud: Misdemeanor, up to 1 year prison
Any offense with intent to defraud or mislead: Felony, up to 3 years
Second offense: Automatic felony, up to 3 years
Drug or device violations: Up to 20 years, $1 million fine
That "intent to defraud" language matters. Prosecutors dont have to prove you knew something was wrong. They argue that your marketing claims, your label statements, your product representations demonstrate intent to mislead consumers. Nicholas Puccio, a New Jersey chiropractor who sold SARMs products, pled guilty in 2024 to introducing an unapproved new drug with "intent to defraud and mislead." He faces up to three years.
And this is were the classification trap destroys people. You think your selling a dietary supplement. The FDA decides your selling an unapproved new drug. The aegeline in OxyElite Pro wasn't proven safe - suddenly it's an adulterated substance. The SARMs in bodybuilding products? Those are unapproved drugs, not supplements. A disease claim on your label? Your supplement just became a misbranded drug under federal law. The product classification itself becomes the basis for felony charges.
What To Do Right Now
If FDA inspected your facility and left a Form 483, the clock is already running. You have 15 business days to respond. That response needs to address each observation individually. It needs to describe the corrective actions you've taken or are taking. An inadequate response leads to a Warning Letter. A Warning Letter can lead to injunction, seizure, or criminal referral.
Everything you said during the inspection is already on record.
Here's what most business owners don't realize: every document you handed the inspectors voluntarily becomes potential evidence. Every question you answered - even the casual ones, even the ones that seemed unrelated - is documented. The cooperation that felt like the right approach in the moment may have built the government's case. FDA investigators are trained to gather evidence during routine inspections. The friendly questions were building blocks.
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What you need to do NOW:
Stop discussing the investigation with FDA without legal counsel present
Do not destroy any documents - document destruction becomes its own federal charge
Gather copies of all Form 483 observations
Understand whether your products might be classified as drugs rather than supplements
Contact an FDA defense attorney before responding to the 483
The 15-day response deadline is real but its also your opportunity. A well-crafted response can prevent a Warning Letter. A comprehensive corrective action plan can stop the escalation. But it has to be done right. It has to address the actual regulatory concerns. And it has to be prepared with full understanding of the potential criminal exposure.
Todd Spodek understands FDA enforcement. He knows the difference between cases that can be resolved with corrective action and cases where criminal defense is the immediate priority. He knows what OCI involvement looks like and how to recognize when an investigation has shifted from civil to criminal.
When Your Ready
If FDA has inspected your supplement business - whether you received a Form 483, a Warning Letter, or suspect the investigation has escalated - Spodek Law Group can help you assess exactly where you stand.
The consultation is free. Theirs no obligation.
What you'll get is an honest assessment. Are you still at the 483 stage where a proper response might prevent Warning Letter? Has it already escalated to OCI? What's your Park Doctrine exposure? What are the realistic outcomes - not best-case scenarios, but actual possibilities based on how these cases proceed?
Call us at 212-300-5196. The 15-day clock is running. The earlier you have counsel, the more options exist. Once a case gets referred to the DOJ, the options narrow dramatically.
Don't wait for the next letter.
Were here when you need us.
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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.
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