The Food and Drug Administration (FDA) is tasked with regulating the design, manufacture, marketing, and sales of prescription drugs, foods, tobacco, medical devices, dietary supplements, and numerous other products. Part of that regulatory process involves investigating alleged variations from required practices, enforcing violations, and penalizing wrongdoers.
The FDA defense lawyers at Oberheiden P.C. guide corporations, healthcare businesses, and individuals through the FDA compliance and FDA investigation procedures, helping them avoid the hassle of an FDA enforcement action or mitigating the damage of one, if it has begun. Numerous clients in Miami have benefited from our legal advice as they navigate through the maze of regulations set up by the FDA and avoid the significant penalties for violating them.
The FDA Enforcement Process in Miami
The FDA can decide to initiate an enforcement action based on the results of a pre-scheduled investigation, a whistleblower report, or from the response to a survey.
In many cases, the first indication that a company will have of an FDA enforcement procedure is the investigator handing them a Notice of Inspection on FDA Form 482.
Similar to a warrant, Form 482 will detail what the inspector is there to investigate. This will include details about the scope of the investigation, including what files, records, documents, or samples the investigator will want to see.
After the inspection is complete, the investigator will provide a list of Inspectional Observations on FDA Form 483. This will detail any FDA violations that the investigation uncovered. The Form will also include any corrective actions that the company can take to fix those problems, often with a deadline to do so.
The investigator will also prepare an Establishment Inspection Report, or EIR. The EIR is a more detailed report of the investigation, and includes all of the activities that the investigator saw during the visit.
Based on the EIR, the FDA will classify the inspection in one of three ways:
- No Action Indicated: Based on the inspection, the FDA determines that no further regulatory action is needed
- Voluntary Action Indicated: Violations were found during the inspection, but the FDA decides that the best way to correct them is to schedule a re-inspection and for the company to correct the problems before then
- Official Action Indicated: Violations were found during the inspection and the FDA decides to initiate a compliance, regulatory, or administrative action
Possible FDA Enforcement Actions
If violations are found during the inspection, the FDA has a variety of enforcement mechanisms at its disposal.
One of the most common responses by the FDA is to initiate administrative proceedings against the company over the alleged violation. While the potential penalties from these proceedings are limited to the services that the FDA provides, they can still cripple a company by, for example:
- Ordering product recalls
- Suspending the company’s FDA registrations
- Detaining products that are allegedly in violation of the federal Food, Drug, and Cosmetic Act (FD&C)
In Miami, a common administrative sanction is to detain or seize products or foods that have been imported from abroad and that do not comply with the strict requirements of the FD&C Act.
Another common sanction is an injunction, or a court order, to correct an alleged FDA violation and to fix the harm that it has caused. Injunctions may require a company to:
- Stop manufacturing certain medical devices or drugs
- Take specific actions to correct the findings from the inspection
- Disgorge the proceeds obtained from any FDA violation
Finally, the FDA can pursue criminal penalties for a violation through its Office of Criminal Investigation (OCI). This is the most severe step that the FDA can take against a company or individual, and focuses on products or other business practices that have been deemed to be a danger to public health or that amount to FDA fraud. This can include:
- Healthcare fraud
- Counterfeit drugs
- Misbranded products
- Fraudulent substitutions
- Ineffective drugs or cures
- False statements made to the FDA during an investigation
Frequently Asked Questions (FAQs) About FDA Enforcement in Miami
Does the FDA Have Regional Offices in Miami?
Yes, while the FDA’s district office for the Florida region is in Maitland, outside of Orlando, Miami has three FDA offices in the city, including an Office of Criminal Investigations and an international mail facility at the Miami International Airport. With such a heavy presence of FDA enforcement officers in the city, Miami sees a disproportionate number of FDA enforcement actions.
Can FDA Enforcement Actions Lead to Other Criminal Charges?
Yes. If the FDA conducts an inspection and uncovers evidence of a crime, there are a myriad number of criminal charges that the target of the investigation can face. The FDA’s OCI is not confined to charges of healthcare or FDA fraud. Instead, these investigations can uncover evidence that leads to other criminal charges for:
- False Claims Act
- Anti-Kickback Statute
- Stark Law
- Mail fraud
- Wire fraud
- Import violations
- Money laundering
These offenses are severe in their own right. Some of them carry decades in prison, on top of the underlying FDA fraud allegation that led to them.
What is the Best Way to Avoid an FDA Investigation?
The best way to avoid a protracted FDA investigation is to have a strict compliance strategy in place so the company does not fail the initial FDA inspection. By having a compliance strategy and then sticking to it every day, companies that are regulated by the FDA can be prepared for the inevitable inspection by the agency. By passing the inspection with flying colors, the company can avoid further scrutiny and the hassle of a drawn-out FDA re-inspection or official action.
The lawyers at Oberheiden P.C. can help put together an effective compliance strategy for your business.
When is the Best Time to Hire a Lawyer?
Immediately. By hiring an attorney as soon as you are aware of a potential FDA inspection, you give your defense team the time they need to conduct an internal review of the facts of your case. This gives them the opportunity to find out what the inspection is likely to uncover, which can then inform you of the best defensive strategies that may be necessary. Delaying before hiring an attorney can put your legal defense team in the difficult position of playing catch-up to the FDA enforcement action.
Why Doesn't Oberheiden P.C. Call Itself the Best FDA Enforcement Defense Firm?
Because we prefer to let our cases speak for themselves. Our firm is full of top-notch senior attorneys who have experience on both the defense and the prosecution side of FDA enforcement actions. That experience gives the lawyers at Oberheiden P.C. the ability to predict the moves that the FDA will make in a given case, which we can then use to adopt an efficient and appropriate defensive strategy. In some cases, this can mean invoking our client’s rights and putting it on law enforcement to collect the evidence of alleged misconduct. In other cases, it means being proactive and showing the FDA attorneys that the alleged violations found during the inspections were based on faulty data or a mistake.
Why an FDA Enforcement Defense Lawyer from Oberheiden P.C. is Necessary
Companies, executives, and individuals who are being investigated by the FDA should strongly consider hiring an FDA enforcement defense lawyer from Oberheiden P.C. to protect their rights and interests. Going through the FDA investigation and enforcement process without skilled and experienced legal representation can lead to significant legal liability, and potentially even criminal charges, that were avoidable.
One of the most deceptive parts about an FDA inspection is how innocuous it can seem at the time. When inspectors come to a business with a Notice of Inspection, or FDA Form 482, many businesses in Miami let them in, thinking that they have nothing to hide. However, the FDA regulations that these inspections cover are extremely widespread and difficult to follow. Especially if the facility does not already have a solid FDA compliance system in place, these inspections can uncover significant regulatory violations that the owner or executives were unaware of before the inspection.
Once the inspection uncovers a violation, the FDA can respond in a variety of ways. None of them are good for the business. Some of them can lead to serious financial penalties, including disgorgement, which can cripple the business. In the worst cases, the FDA’s OCI can get involved and file criminal charges for fraud or other healthcare violations.
By hiring an FDA enforcement defense lawyer, individuals and corporations can take the steps necessary to insulate themselves from administrative, civil, or even criminal liability. Getting an attorney on board as soon as possible is essential, as it can allow the lawyer the time he or she needs to get ahead of the FDA investigation.
At Oberheiden P.C., our staff of attorneys is filled with former FDA inspectors and lawyers who know first-hand how FDA investigations tend to proceed. This lets them predict the agency’s next moves in a given investigation, which can help our clients prepare a better defense strategy that protects their interests and future. Contact us online or call our law office at 888-680-1745 for legal representation in Miami.