FDA Form 483 Remediation

Receiving an FDA Form 483 After an Inspection Can Present Substantial Risks. Here’s What You Need to Know About How to Respond

The U.S. Food and Drug Administration (FDA) routinely conducts inspections to assess companies’ compliance with the Food, Drug, and Cosmetic Act (FD&C Act) and related acts, and its enabling regulations. These inspections can have several outcomes, one of which is the issuance of FDA Form 483. Issuance of FDA Form 483 means that the FDA’s investigators uncovered violations during their inspection—and that remediation may be necessary to avoid further consequences.

Notably, the FDA states that its investigators “are trained to ensure that each observation noted on the Form FDA 483 is clear, specific and significant.” However, as the FDA also makes clear, FDA Form 483 is not “intended to be an all-inclusive list of every possible deviation from law and regulation.”

As a result, responding to an FDA Form 483 presents multiple risks. On the one hand, companies must ensure that they appropriately remedy all “significant” statutory or regulatory violations identified in the form. On the other hand, companies must also address the possibility that, “[t]here may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483,” and that could still present risks for FDA enforcement in the future.

Federal Compliance Lawyers and Former FDA Personnel Assisting with FDA Form 483 Response

At Oberheiden P.C., we guide companies step-by-step through the FDA Form 483 remediation process. If your company has received an FDA Form 483 or a warning letter at the conclusion of an inspection, we can help you understand what is at stake, what you need to do, and how and when you need to do it. With a team that includes both career federal compliance lawyers and former FDA personnel, we are intimately familiar with all aspects of FDA compliance, and we can provide your company and personnel with the tools, resources, and insights needed to effectively manage FDA compliance going forward.

You Received an FDA Form 483. What Now?

If you have received an FDA Form 483 during an inspection, you will have the opportunity to discuss the form with the FDA’s investigators (if this opportunity has not already passed). This is a critical opportunity, and it is an opportunity that you should leverage to the fullest extent possible. Our lawyers and consultants can work with the FDA’s investigators on your behalf; and, in doing so, we will focus on achieving two main goals:

• Demonstrating that allegations of violating the FD&C Act or the FDA’s regulations are misguided; and/or, 
• Gathering additional information so that we know what exactly our clients need to do in order to satisfy the investigators’ concerns and address the cited objectionable conditions. 

At this point, it is important to clarify that receiving an FDA Form 483 doesn’t necessarily mean that any negative repercussions will follow. As the FDA explains, “[t]he FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company . . . [to] determine[] what further action, if any, is appropriate to protect public health.” Thus, while the issuance of an FDA Form 483 presents risks, it also presents an opportunity to remediate any compliance issues before they lead to FDA enforcement action.

This is critical to keep in mind. Regardless of the events that have transpired to date, your company still has time to come into compliance (or dispute the investigators’ allegations of noncompliance). With that said, at this point your company is on the FDA’s radar, so you need to make sure that your company’s response to its FDA Form 483 is appropriate.

How We Assist Companies with FDA Form 483 Remediation

We take a comprehensive approach to helping companies respond to FDA inspections that includes not only FDA Form 483 remediation, but also identifying any additional compliance concerns that need to be addressed. This way, our clients know that they can confidently move forward with bringing their products to market, and they can manage FDA compliance with a solid foundation.

Our services for companies that have received an FDA Form 483 following an inspection include:

Reviewing the FDA Form 483 in Detail

We will begin by reviewing the FDA Form 483 in detail. When responding to allegations of noncompliance from the FDA, it is critical not to make any oversights or assumptions. We will determine what exactly the FDA’s investigators are alleging so that we can formulate your company’s response appropriately.

Independently Assessing the Company’s FDA Compliance

Upon receiving an FDA Form 483, a company should independently assess each of the allegations included in the form. The company should also independently assess its FDA compliance efforts in all other areas—as FDA Form 483 only addresses violations identified during the FDA’s inspection, and these inspections generally are not comprehensive. By conducting an independent assessment of your company’s FDA compliance, we can determine precisely what your company needs to do to avoid FDA enforcement.

Communicating with the FDA’s Investigators

If we have the opportunity to do so, we will communicate with the FDA’s investigators who conducted the inspection to learn more about their conclusions, question their assumptions, and clarify their expectations regarding your company’s FDA Form 483 remediation efforts.

Developing and Implementing a Corrective Action Plan

After assessing your company’s FDA Form 483 and gathering all necessary information, we will develop a corrective action plan. As the FDA states, “[c]ompanies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.” Since we have a clear understanding of the FDA’s expectations, we can prepare a corrective action plan that protects your company, and then we can help your company implement this plan as efficiently as possible.

Demonstrating Remediation and Compliance to the FDA as Warranted

Depending on the circumstances, it may be necessary or prudent to follow up with the FDA after implementing your company’s corrective action plan to demonstrate your company’s compliance. We can advise you regarding the steps your company should take after implementing its corrective action plan, and we can guide your company through these steps as well.

Assisting with Ongoing FDA Compliance Management

Once we’ve resolved your company’s FDA Form 483, we can provide assistance with FDA compliance management on an ongoing basis. Our team is well-versed in all aspects of FDA compliance, and we can help your company take all of the steps that are necessary to mitigate its risk of facing FDA enforcement action in the future.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: Responding to an FDA Form 483

Contact the FDA Compliance Team at Oberheiden P.C.

Has your company received an FDA Form 483 following an inspection? If so, we can help, but it is important that you contact us promptly. To speak with a lawyer or consultant on our FDA compliance team in confidence as soon as possible, call 888-680-1745 or contact us online today.