The Food and Drug Administration (FDA) is the federal agency that regulates all aspects of the creation, manufacture, and sale of prescription drugs, medical devices, dietary supplements, tobacco, food, and numerous other products on the market in the U.S. A big part of that job is to investigate business practices that potentially run afoul of the law and to penalize wrongdoers.
Businesses in San Francisco that are under investigation by the FDA should strongly consider hiring a defense team that understands this complicated process. The FDA defense lawyers at The Criminal Defense Firm help healthcare businesses, corporations, and other individuals who are being scrutinized by the FDA to navigate the complicated FDA investigation process and protect them from legal liability.
How the FDA Enforcement Process Works in San Francisco
Generally, the FDA initiates its investigation and enforcement process after a pre-scheduled inspection uncovers potential violations. However, the process can also begin after a whistleblower brings information to the agency.
For the company that is the target of the investigation, the first indication that they usually have of the FDA action is the arrival of an FDA agent from the agency’s San Francisco office. The agent will have an FDA Form 482, or a Notice of Inspection. This Form outlines the scope of the inspection and the records that will have to be disclosed.
When the inspection is finished, the FDA inspector will provide a copy of FDA Form 483 – Inspectional Observations. This Form will list any FDA violations that were found during the inspection, provide any corrective actions that the company will have to take to fix them, and provide a deadline to do so.
The target of the inspection will also receive an Establishment Inspection Report, or EIR. This report has more details of the inspection, including a description of the facts and other activities that the inspector found while onsite. The FDA will use the EIR to classify the inspection based on how it will respond:
- No Action Indicated are inspections that did not find violations deemed worthy of regulatory action by the FDA
- Voluntary Action Indicated are inspections that uncovered potential violations, but the company can voluntarily fix them before a re-inspection is scheduled
- Official Action Indicated are inspections that found violations and that will lead to compliance, regulatory, or administrative action by the FDA
Possible Enforcement Actions for FDA Violations
If the inspection uncovered FDA violations, the agency can take several types of legal actions against the company, based on the severity of the findings:
- Administrative proceedings
- Court orders or injunctions
- Civil liability
- Criminal charges
Administrative proceedings are likely the most common type of action that the FDA pursues for alleged violations of food and drug law and regulations. These are internal reviews of the company’s conduct within the FDA. Because they happen within the agency, the only sanctions that can come from them are those that the FDA has the authority to implement, like:
- Suspending or revoking the company’s FDA registration
- Ordering product recalls
- Detaining products that allegedly violate the Food, Drug, and Cosmetic Act (FD&C)
While these sanctions do not involve civil or criminal liability, they can still cripple a business in San Francisco.
The FDA can also pursue court orders or injunctions to get the judicial system’s help in bringing the company into compliance with the laws that the FDA enforces. For example, the FDA can ask a court to order the company to:
- Cease the manufacture of certain drugs or medical devices
- Take specific actions that address the violations found during an FDA inspection
- Disgorge proceeds the company made from an FDA violation
Disgorgement is one of the heaviest penalties the court can impose outside of a civil or criminal case. Companies that have been engaging in conduct that the FDA has deemed to be wrongful may find themselves with a substantial bill to pay. Violations of a court order amount to contempt of court, which can come with additional fines and potentially even jail time.
Finally, if the violation was severe, the FDA can pursue criminal charges through its Office of Criminal Investigation (OCI). The FDA generally reserves this type of legal action for conduct that it considers to be a danger to public health or that amounts to FDA fraud, like:
- Fraudulently substituting one drug for another
- Misbranding products
- Selling ineffective drugs or cures
- Making false statements to the FDA
- Counterfeiting drugs
The penalties for a conviction for one of these charges can include significant fines and a lengthy prison sentence.
FAQs About FDA Enforcement in San Francisco
Is There an FDA Office in San Francisco?
Yes, while the FDA’s Pacific Regional Office is across the bay in Oakland, San Francisco is home to several of the agency’s offices, including an international mail facility in the San Francisco International Airport. Additionally, the region’s Office of Criminal Investigations (OCI), which handles the criminal cases brought by the FDA, is also nearby in Oakland.
Can an FDA Enforcement Action Lead to Other Criminal Charges?
Yes. The FDA enforcement procedure can lead to criminal charges that are not FDA-related, like:
- Mail fraud
- Wire fraud
- Money laundering
Additionally, evidence uncovered in an FDA inspection can be used to prosecute criminal cases of healthcare fraud, like violations of the:
- Anti-Kickback Statute
- Stark Law
- False Claims Act
In many cases, a different federal agency may prosecute these offenses, like the Department of Justice (DOJ) or the Federal Bureau of Investigation (FBI).
Convictions for these crimes can carry lengthy prison sentences that are served in addition to any prison time that comes from the underlying FDA violation.
Why Doesn't The Criminal Defense Firm Call Itself the Best FDA Enforcement Defense Law Firm?
At The Criminal Defense Firm, we like to let our history of successful cases and our attorneys’ backgrounds speak for themselves.
As an FDA enforcement defense firm, we have represented countless companies at all stages of the FDA’s inspection and enforcement process. In some cases, we have helped business come up with compliance strategies that have suited their needs and that have stood up to subsequent FDA inspections, effectively insulating our clients from the hassle of a re-inspection and the potential sanctions of an FDA enforcement action. In other cases, we have been called on to represent corporations and individuals who had already been found in violation of FDA regulations. In those cases, our experienced lawyers examined the agency’s case against our client and raised strong legal defenses to the allegations that either stopped the enforcement action from getting any further or mitigated the damages that it caused to the interests of our client.
Those excellent case results come in large part due to the extensive experience that our senior attorneys have in the FDA enforcement field. Many of our lawyers at The Criminal Defense Firm used to work in law enforcement at the FDA. They have prosecuted the same types of cases that they now defend. This gives them invaluable insight into how the agency is likely to proceed as it uncovers evidence of potential wrongdoing. Our clients benefit from that experience by getting a defense strategy that looks long-term and that positions them for subsequent developments in the investigation, rather than a strategy that merely reacts to the government’s case.
When is the Best Time to Get Legal Representation?
The best time to hire a lawyer is as soon as you become aware of the FDA’s intent to inspect your company. Our lawyers can conduct an internal review that uncovers any problems that the FDA is likely to find, before they find it. That awareness can help companies fix potential violations and pass the inspection, or at least reduce the severity of the violation before it gets out of hand.
FDA Enforcement Defense Lawyers from The Criminal Defense Firm
Healthcare companies and individuals in San Francisco who are being investigated by the FDA can be subjected to surprisingly harsh consequences for a violation of food and drug law. Facing an FDA inspection and the investigative process that follows an alleged violation without legal representation drastically raises the odds that you or your company gets sanctioned by this powerful federal agency or even gets charged with a crime.
Unfortunately, many executives underappreciate the potential for an FDA inspection to escalate into legal action. When FDA inspectors come from the agency’s San Francisco office, many businesses let them in and do not monitor the inspection process to make sure it abides by the scope of FDA Form 482. This can lead to a finding of an FDA violation. Even if the company has a stringent compliance system in place, the breadth and detailed nature of the FDA’s regulations can mean that the business is in violation without knowing it and in spite of its best efforts.
If a violation is found, the FDA can take administrative, civil, or criminal action against the company. These carry substantial penalties, the least severe of which can still cause serious problems to the business.
The FDA enforcement defense lawyers from The Criminal Defense Firm can help companies throughout the enforcement process. Our lawyers can help businesses craft and execute excellent FDA compliance strategies that reduce the odds of a violation being found during an inspection. Our lawyers can also monitor the inspection process and help companies navigate the fallout if a violation is discovered.
Contact us online or call The Criminal Defense Firm today at 888-680-1745.