- The FDA investigates many areas such as prescription drugs, foods, medical devices, tobacco, dietary supplements, labelling, and importation.
- In addition to civil proceedings, the Office of Criminal Investigations (“OCI”) is the department of the FDA that investigates criminal investigations, including ineffective drugs or cures, fraudulent substitution products, and false statements made to the FDA.
- Investigations by the FDA begin when the investigator presents their credentials to the company and gives the company an FDA Form 482—a “Notice of Inspection.” It ends when the investigator issues a Form 483—the “Inspectional Observations”—that discusses the results of the investigation.
- After the investigation, the FDA may take several enforcement actions such as civil remedies, injunctions, criminal prosecutions, and administrative proceedings.
- The FDA investigative process is complex; consider hiring an FDA defense attorney to guide you through the process and respond to any regulatory requests.
Experienced FDA Defense Team
If you are under investigation by the FDA, now is the time to take prompt action in your defense. The FDA has ramped up its investigative strategies and has become very progressive in issuing warning letters to companies.
It has also regularly threatened immediate corrective action or further enforcement as well as severe criminal penalties for violations of FDA laws.
This is especially important now because of the increased risk of fraud in connection with healthcare providers and medical devices due to the complications created by the coronavirus.
Do not fall prey to a protracted FDA investigation without first understanding your rights and receiving the advice of an FDA defense lawyer.
At Oberheiden, P.C., our attorneys include former FBI agents, former U.S. attorneys, and former prosecutors, all ready to defend you and your company against unwarranted charges and mitigate the stages of the investigative process.
Put Oberheiden, P.C. on your side to fight for your freedom, liberty, reputation.
What FDA Investigations Focus On
The investigative purview of the FDA is quite broad. Some of the most common topics the FDA investigates include prescription drugs, foods, medical devices, tobacco, dietary supplements, product substitutions, clinical investigations, labeling, importation of regulated products, and the manufacture, sale, and distribution of products.
The Role of the Office of Criminal Investigations
The Office of Criminal Investigations (“OCI”) is the department of the FDA that coordinates and investigates criminal investigations. OCI investigations often signal very serious investigations regarding products that are a danger to the public health.
The OCI investigates many types of criminal conduct, including ineffective drugs or cures, fraudulent substitution products, false statements made to the FDA during an investigation, health fraud involving medical devices, counterfeit and misbranded products, and situations where compliance has failed to correct a product that has a high risk of harm to the public.
The job of the OCI is to protect the American public by undertaking these criminal investigations. Such investigations involve scrutinizing the business practices of companies, obtaining and executing search and arrest warrants, gathering evidence, arresting individuals responsible for FDA violations, and then bringing them before the DOJ for criminal prosecution.
The Process of an FDA Investigation
The FDA begins an investigation for many reasons such as in response to a survey, a reported problem with the company, or sometimes based on a pre-scheduled investigation.
At the beginning of an investigation, the investigator will present their FDA credentials and identification and give the company to be inspected an FDA Form 482, which is a “Notice of Inspection.”
The Form 482 will outline what the inspector may and may not investigate, including files, records, and sometimes samples. These investigations wary based on the nature of the company, the size of the company, and the products manufactured, distributed, or sold.
For instance, an inspection for a food company will focus upon whether any food, drugs, or other products have been prepared under safe conditions, whether any items have been adulterated, and whether the process meets safety standards for the public health.
When the inspection is completed, the inspector will discuss its conclusions with the company’s management. The inspector will issue a Form 483, which is the list of “Inspectional Observations.”
The Form 483 will discuss whether the investigator found that any food, device, drug, or other product has been adulterated or is injurious to public health. The company can then use the Form 483 to prepare for corrective action, which the inspector will sometimes set a timeline by which these corrections should be completed.
The investigator then prepares an “Establishment Inspection Report” (“EIR”), which reports in detail all the activities and factual findings that the inspector uncovered from the inspection of the company’s premises.
Following the “EIR,” the FDR can classify the company’s inspection in the following ways:
- No Action Indicated (“NAI”): The FDA determines that further regulatory action is not warranted based on the observations revealed from the inspection.
- Voluntary Action Indicated (“VAI”): The FDA determines that a re-inspection is warranted, though there are typically no further compliance or regulatory actions needed.
- Official Action Indicated (“OAI”): The FDA determines that compliance, regulatory, and/or administrative actions are warranted and that certain products cannot be approved unless the company undertakes a preapproval inspection.
Possible FDA Enforcement Actions and What to Do If You Are Under Investigation
After the investigation, the FDA may take several enforcement actions against the company. The FDA could seize the unlawful product that fails to meet FDA specifications.
The FDA could also issue an injunction—which orders the company to cease certain operations or requires the company to undertake certain conditions or to disgorge its ill-gotten gains.
The FDA could also pursue a criminal prosecution as a possible enforcement action. This is true even if the FDA is also pursuing a civil investigation and seeking civil remedies.
Administrative proceedings are a further popular avenue of enforcement. The FDA may issue administrative orders for product recalls, suspensions of registrations for companies, or product detentions for certain flagged products that are imported and suspected of being in violation of FDA standards—such as a violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), which is enforced by the FDA.
These potential enforcement avenues are both complex and plentiful. This only stresses the importance of retaining counsel to advise you on the FDA’s investigation as soon as possible.
An experienced FDA defense attorney can respond to various stages in the FDA’s investigation, lessen or mitigate certain requests for testimony or documents, and work with regulatory partners to receive a result most favorable to you.
FDA Responses to the Coronavirus
The FDA has taken a proactive role in responding to the coronavirus in order to uphold safety standards and promote the public health of the United States.
Below are recent actions taken by the FDA to combat coronavirus implications:
- On June 17, 2020, the FDA released a News Release noting that it had issued warning letters to three companies for “marketing adulterated and misbranded COVID-19 antibody tests.” The FDA stated that these tests are important in fighting the pandemic and that issuing warning letters will continue for companies that continue to market adulterated or misbranded test kits.
- On June 2, 2020, the FDA released a Press Release that describes a temporary restraining order against Fort Davis resident Marc “White Eagle” Travalino for offering fraudulent coronavirus cures and treatments. The injunction against Travallino is to prevent further sales of false COVID-19 cures.
- On June 1, 2020, the FDA released an FDA Statement describing the additional steps it has taken to help ensure the widespread access to hand sanitizers during the pandemic. It also updated guidance to provide additional clarification on the manufacturing process of hand sanitizer products to ensure that harmful levels of impurities are not present in the hand sanitizers.
- On May 19, 2020, the FDA released an FDA Statement noting that it has been working to support the U.S. food and agriculture sector to ensure that Americans continue to have access to a “robust food supply.” The U.S. Department of Agriculture (“USDA”) and FDA announced a Memorandum of Understanding (“MOU”) to prevent interruptions at FDA-regulated food facilities.
Need Advice with FDA Investigations?
Being investigated by the FDA can make a company apprehensive about the process and consequences of an inspection.
A conclusion by the FDA that a company is deficient in some manner or may need to re-adjust or halt its operations until further inspections and/or approval is satisfied could seriously damage your company’s profit margin and reputation.
It is critical that you respond to an FDA investigation thoroughly and truthfully while still understanding that you have rights.
An FDA defense attorney can guide you through this process by working with regulatory partners, seeking clarification of vague standards, and objecting to questionable requirements when needed.
At Oberheiden, P.C., our team of FDA defense attorneys has the experience needed to prepare your company for an FDA investigation and defend you against unwarranted and unsubstantiated charges.
If you are being investigated by the FDA, call us today at 888-680-1745 or contact our office for a free consultation.