FDA Consent Decree

An FDA Consent Decree represents a serious step in FDA enforcement. To obtain a consent decree the FDA must work with the Department of Justice (DOJ) trial attorney to file a complaint in Federal District Court. This type of filing requires a response otherwise a default judgment will be entered against the defendant facility. In the majority of cases the defendant facility does not fight the allegations, but settles the matter through a FDA Consent Decree also known as an injunction.

The FDA Consent Decree requires a complete halt in operations until certain conditions are met. This typically focuses on previous violations for labeling (misbranding) or Good Manufacturing Practices (GMPs; adulteration). A FDA Consent Decree will require corrections and verification audits passed prior to resuming operations. The FDA Consent Decree may also require a recall. The recall can be quite wide in scope covering lengthy periods of time for a single product or an entire inventory.

The best practice is to avoid a FDA Consent Decree. Often this means engaging counsel to respond to FDA Warning Letters or Form 483s. Proactive, timely, and appropriate responses at early stages can keep a FDA Consent Decree from occurring.

When the DOJ trial attorney becomes involved it is important to engage regulatory counsel and local trial counsel to negotiate the best possible FDA Consent Decree. The negotiation can focus on limiting the scope of the recall, for example, or expanding deadlines for various required action. The simple changes can make managing the implementation of the Consent Decree easier and more streamlined. Following the negotiations it is important to fully comply with a FDA Consent Decree. Each deadline in the Consent Decree must be met.

It is important to remember, once a Consent Decree is filed and issued by the Federal court, non-compliance becomes grounds for contempt. This places a greater emphasis on compliance than what is normally experienced in a Warning Letter or Form 483 scenario.

Please contact our Washington D.C. or Charlotte office with your FDA Consent Decree question.

FDA Form 483 – Inspectional Observations

Overview and Responses

The FDA Form 483 Inspectional Observations is perhaps the best known regulatory action. The FDA Form 483 follows a facility inspection. A facility inspection may be conducted for both foreign and domestic facilities. It is also conducted for all types of facilities, dietary supplement, food, drug, medical device, or animal drug or food. The Form 483 is issued by the inspecting agent and is not reviewed by a Compliance Officer or District or Center Director. It indicates minor violations. Major violations will be issued in a Warning Letter, which may precede or be concurrent with a Form 483. A Form 483 is not associated with import inspections. Import inspections follow a series of separate notifications (FDA Notice of Detention, Refusal, Hold, etc.). A brief overview of the Form 483 is provided below.

FDA Form 483 Inspection

Understanding the Form 483

FDA Form 483 Inspection or Inspectional Observations as it is formally known refers to the most common enforcement action used by the FDA. The FDA is imbued with the authority to conduct warrantless inspections of US facilities. The FDA also exercises authority to inspection foreign facilities. From this inspection the FDA compiles a list of observations in a form known as Form 483 Inspectional Observations.

FDA Form 483 Inspection observations are issued by the FDA field agent and reflect their opinion on compliance with Good Manufacturing Practices (GMP). GMP compliance is not limited to manufacturers, but also extends to varying degrees to distributors, repackagers/relabelers, and specification developers.

FDA Enforcement Guidance

If you have received a 483, warning letter, import detention order or need immediate assistance during an FDA inspection, please call 202.765.4491 or e-mail msanchez@fdaatty.com

What We Offer

Our firm can assist you in preparing an effective response to any FDA or USDA enforcement action. Common enforcement actions from the FDA 483 and/or warning letter, managing a recall, responding to an import detention, or petitioning for removal from an import alert. We can intervene directly with FDA field agents, compliance officers, and recall coordinators to provide you the best enforcement outcome possible. We also provide you with direction and hands-on assistance in developing and implementing a remediation plan to ensure your GMP quality system will be in compliance with the FDA regulations.

We also represent doctors in FDA criminal investigations into counterfeit drugs and retailers in SNAP (food stamp) violations.

We can:

Analyze the findings of the FDA 483 and/or warning letter.
Develop a plan of action to remedy any deficiencies.
Develop a timeline for implementation.
Lead and/or assist in implementation of the plan.
Act as an interim management representative.
Be a resource to answer questions from you or the FDA during your efforts to correct the noted deficiencies.

Please contact us for a free consultation.

What is a FDA 483 Warning Letter?

An inspection can be an unwelcome surprise. The U.S. Food and Drug Administration (FDA) uses what is known as FDA Form 483, referred to as “Notice of Inspectional Observations,” to cite major violations discovered during an inspection. The 483 notice is issued by an FDA field investigator after an on-site inspection; it lists deficiencies in your quality system, but can also include other violations like labeling, failing to file an adverse event report like an MDR or failing to properly issue a recall. The observations contained in every Form 483 are based on the inspector’s evaluation of your operation and on his or her interpretation of the regulations and how they relate to your operational good manufacturing practice (GMP) quality system.

The field inspector will submit the finalized 483 notice to his/her superiors, and based on the severity of the findings, an FDA warning letter may be issued to your firm.

What do I need to do if I receive a FDA 483 or Warning Letter?

You must respond to the FDA 483 warning letter in a timely manner and identify your plan to implement a corrective action program to remedy the findings. A detailed response to each finding will also be necessary for each item addressed. The quality and promptness of our response to this letter is extremely important. Often, the FDA will require a company who receives a 483 warning letter to hire a consultant to assist in the resolution of the findings. Even if the FDA has not made this mandatory as a result of your particular warning letter, the FDA looks at this voluntary action as a commitment by your company to bring it back into compliance.

The FDA Detained my Shipment from Entering the US, Now What?

There are a number of reasons a shipment can be detained at the point of entry. Unapproved medical devices, misbranding (improper labeling), and potential adulteration are among the most common violations. We can help you quickly identify the reason for detention and work diligently to resolve the issue. A quick and effective response will help you avoid a warning letter, publication on the import alert list, or other penalties.

Recalls

If you’ve received a product complaint or report of an injury or illness, then you need a rapid response. Our firm can help you manage all aspects of a recall or adverse event/illness report.

Import Alerts: If the FDA customs detained your product an immediate response is required to avoid listing on an Import Alerts. Import Alerts are publicly published notices of violations that also allow the FDA to detain every shipment that enters the country. If you’ve already received an Import Alert, such as Import Alert 89-08, we can help petition the Agency for removal. Our firm offers experience working with clients from South Korea to Canada and Europe to petition the FDA for removal from an Import Alert.

“This statement has not been evaluated by the Food and Drug Administration.” When you see this disclaimer on the label of a dietary supplement, you might think the FDA does not regulate what you can or cannot say about functional foods or dietary supplements. You are not alone in this feeling. Many companies, including large and well-established ones, have misinterpreted the disclaimer. The FDA does regulate functional foods (like fortified food and drinks) and dietary supplements/natural remedy products distributed in the United States. In fact, the FDA has recently stepped up its enforcement efforts against companies for safety and labeling violations, which included issuance of warning letters, product seizures, and civil and even criminal penalties. It’s more important than ever to be sure that your products comply with applicable regulations.

Our firm provides a broad range of international legal and regulatory services related to the production and marketing of dietary supplements.

Labeling Review:FDA regulations require that certain information appear on food and dietary supplement labels, such as statement of identity, net quantity of contents, and ingredient information. The information must also be formatted in accordance with the regulations. By law, companies may make three types of claims on their products: health claims,structure/function claims, and nutrient content claims. Different requirements generally apply to each type of claim. Unless specifically allowed by regulation, a company is prohibited from making labeling claims that imply its food products diagnose, cure, mitigate or prevent disease.

Our firm conducts label and ingredient reviews for all functional foods and dietary supplements in accordance with FDA regulations. This includes review of structure/function claim, health claims, and nutrient content claims, as well as the formatting of the labeling.

The firm also can help you file a 30-Day Structure/Function Claim Notification with the FDA for your dietary supplements.

Advertising Review: Our firm provides advertising counseling for your functional foods and dietary supplements to ensure conformance with regards to third-party testimonials and websites, social media, claim substantiation (amount of scientific support) and various other Federal Trade Commission (FTC) regulations.

Facility Registration and Prior Import Notice: The FDA requires facilities that manufacture, process, pack or store foods and dietary supplements marketed in the U.S. file registrations with FDA. Under theBioterrorism Act, foreign food and dietary supplement manufacturers must also register with the FDA and provide prior notice of import before their products arrive in the U.S. We can assist you with registration and filing Prior Import Notices and will work closely with your Customs broker to ensure compliance with the Bioterrorism Act and Prior Import Notice requirements.

Adverse Event Reporting & Record Keeping: Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a dietary supplement company whose name appears on the product label must report to the FDA certain adverse events associated with the product and maintain reports of adverse events. Our firm helps clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance.

Export Certificates: Struggling to determine whether you need a n Export Certificate to Foreign Governments, Certificate of Exportability, or Certificate of a Pharmaceutical Product? Not sure whether to use Form 3613a or 3613b? We can help you apply for the right export certificate for your device. Our firm offers the experience to make the process simple and straightforward, eliminating confusion on what forms and attachments to include. Whether your already selling the product in the US or only looking to export we can help.

Import Alerts: If the FDA customs detained your product an immediate response is required to avoid listing on an Import Alerts. Import Alerts are publicly published notices of violations that also allow the FDA to detain every shipment that enters the country. If you’ve already received an Import Alert, such as Import Alert 89-08, we can help petition the Agency for removal. Our firm offers experience working with clients from South Korea to Canada and Europe to petition the FDA for removal from an Import Alert.

Warning Letter & Border Detention Assistance: If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to “fix” a deficiency so that you wouldn’t have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast. We can help you respond and take appropriate actions so you can get back to business. Contact the firm as soon as possible for a free initial consultation.

There are many other components to our practice, including:

Interpretation of scope of relevant legislation and regulations;
Analysis of regulatory status and assistance in obtaining approval of ingredients and packaging material components;
Compliance advice on labeling and point-of-purchase material, including health-related claims;
Advise on product certificates, traceability issues, and product recalls;
Advise on advertising claims and promotional materials, including electronic media;
Food additive approvals in the EU, US, and China;
Manufacturing practices compliance; and
Import and export issues.

Our firm represent clients in negotiations on matters related to food and dietary supplements with various regulatory agencies including the Food and Drug Administration, the US Department of Agriculture, the Environmental Protection Agency, and the Federal Trade Commission.

Companies in the food and beverage industry work in an environment of complex regulation, thin margins and low barriers to entry for competitors. In addition, more consumers are paying closer attention to what they eat and how it is produced and prepared. In light of increased food recalls, there are rising concerns about food allergens and other food safety issues, which have increased regulation and regulatory enforcement. Many competitors respond by developing more highly value-added production lines, increasing capital demands, and requiring greater manufacturing sophistication for all companies. To succeed, companies need to execute efficiently, maintain careful and thorough regulatory compliance programs, and constantly innovate to maintain their position in the market.

Our firm provides a broad range of international legal and regulatory services related to the production and marketing of finished food, food ingredients, and food contact materials (including packaging materials).