What is an FDA Warning Letter?

Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a warning letter where there is an indication that some violation, non-compliance, or deficiency has occurred. These warning letters are notifications to individuals from the FDA that a part of their business or FDA-regulated product contains a serious violation or there were issues identified and requires prompt corrective action. These warning letters are public and, as a result, can create many problems for your company. Warning letter response is important and failure to respond to an FDA warning letter can lead to civil fines, seizure of the product, registration suspension, injunctions, product recalls, detention, import alerts, and the complete forfeiture of the right to develop and sell the product. In some cases where public safety is threatened or where there was intent and recklessness involved, the warning letter can lead to a target letter and criminal prosecutions.

Recipients of FDA warning letters will only have a limited time to respond. It is therefore critical for your defense to hire an attorney experienced in FDA violations and deficiencies and how to handle the warning letters issued to you. An FDA attorney will help you understand the violations described in the warning letter and prepare for the next steps. This article, drafted by the FDA defense attorneys at Oberheiden, P.C., describes FDA general warning letters, their structure and details, and what you should do if you received a warning letter.

Structure of General FDA Warning Letters

FDA Warning letters will generally follow the same structure. The letters will list the regulated product, the individual recipient and their business, and the issuing FDA office. The FDA warning letters will also identify the regulation or statute—such as the Federal Food, Drug, and Cosmetic Act (“FD&C Act”)—that is being violated or is deficient. The FDA Warning Letters will then describe the nature of the violation or deficiency in detail, including why the FDA believes that the violation or deficiency is a matter of public concern. Examples of violations or deficiencies include the following:

• Failure to qualify for exemption;
• Failure to investigate an identified discrepancy;
• False labeling of an FDA-regulated product;
• Failure to follow mandatory labeling requirements;
• Failure to follow the proper manufacturing processes;
• False representations about what the FDA-regulated product does;
• Failure to have an adequate monitoring system to prevent contamination;
• Failure to establish appropriate procedures to prevent contamination;
• Flawed or deficient design process;
• Failure to have an FDA marketing authorization order when required;
• Failure to include within the labeling appropriate directions for use of the products;
• Using adulterated or misbranded products; and
• Failure to substantiate the product with credible scientific research.

The FDA warning letter will then explain what corrective action measures must be taken, provide a timeline by which the company must make the changes, and describe the consequences of failing to address or comply with the letter.

Towards the end of the letter, the FDA will note and make clear that it is the recipient’s responsibility to ensure that its products and its sales process comply with the FD&C Act and its implementing regulations. The FDA urges recipients to address any deficiencies and violations described in the letter as soon as possible. The FDA will then request that the recipient prepare a written response—typically within 15 days—describing the specific steps you plan to take to address any violations or deficiencies and prevent them from recurring. This includes detailing the corrective steps your company will take to bring its products or operations into compliance; providing the necessary documentation; and outlining the plan for ongoing or continuous compliance. Some letters will explain the legal consequences for failing to address the letter.

“The FDA is an aggressive agency dedicated to investigating individuals and their businesses for violations and deficiencies regarding FDA-regulated products. If the FDA receives information that the public may be harmed by a potentially dangerous or harmful product, it will waste no time issuing a warning letter. And in cases where these letters involve significant violations and important FDA regulatory provisions, if the matter is not addressed, the FDA may initiate enforcement action and, in severe cases, it could lead to a target letter.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

What You Should Do When You Receive an FDA Warning Letter

If you received an FDA warning letter, the first thing to do is not to panic. There are proactive steps that you can take to address the matter quickly, reduce your liability exposure, and limit media attention. The most important step to take is to hire an attorney experienced in handling FDA warning letters. Your attorney will help you interpret what the FDA is asserting, respond to the agency, and take corrective steps. This is critical to avoid an investigation, liability, or even criminal charges. Make sure your attorney is intricately knowledgeable about the FDA´s rules, regulations, and the process for issuing and handling warning letters.

Your attorney will typically follow the same procedures for FDA warning letters. You and your attorney need to read the warning letter carefully and immediately acknowledge receipt of the letter. The main parts of the discussion with your attorney will be on creating a corrective action plan, drafting a feasible timeline, and developing steps to implement the corrective action plan. When drafting your response to the warning letter, your attorney will help you avoid making unsupported claims. Your response should instead assure the FDA that your company’s operations or the FDA-regulated product are safe, compliant, and effective. The corrective action plan should outline when and how the violations or deficiencies identified by the FDA in the letter will be corrected. In other words, your attorney will help you develop a corrective action plan and timeline.

Conclusion

If you have received a general warning letter from the FDA, there is no time to waste in retaining an experienced FDA defense attorney. Warning letters can lead to multiple consequences and sometimes criminal prosecutions (in severe cases). An attorney can help you with drafting your response letter to the warning letter, implementing a corrective action plan, and ensuring ongoing compliance with the FDA regulations.