A Notice of FDA Action: Definition and Purpose

A man reviews a notice of FDA action on his laptop while working in his warehouse.

A single notice of FDA action has the power to force businesses to shift priorities and provide proof of compliance. 

It’s the last thing anyone who is importing or exporting to the United States wants to see: a dry document declaring that their product is being placed in detention. It’s a frustrating hurdle that slows business and threatens revenue. 

Equipping yourself with the knowledge about the types, purpose, and strategies to navigate the various notices the FDA can send out will help prepare for and even prevent disruptions to your supply chain. It helps assure your product is in compliance.

What is a Notice of FDA Action?

A Notice of FDA Action (NOA) is a piece of written communication from FDA to the manufacturer or distributor of a product. It specifies the nature of the violation and expresses the agency’s concerns about the safety, efficacy, or regulatory compliance of a product in question. 

The notification might ask for additional details, additional evidence, or it might even enforce specific conditions or limitations on the product in query. Either way, any product entering the U.S. that is found to be, or are suspected of being, non-compliant are detained for further physical examination and a notice of FDA action is issued.

Generally, notices will consist of one or more of field examination, product labeling examination, or product sampling.

Field Examination

The most basic of the three, FDA’s field examination simply seeks to make sure that your product was manufactured, packaged, stored, and transported at correct temperatures and in sanitary conditions. 

Product Labeling Examination

FDA’s label examination looks at ingredient listings and checks that any and all information on the label is in English. Food and beverage products are inspected for the correct use of allergen labeling and for drugs, FDA will also cross-reference the product label against its extensive drug listing database.

When it comes to health claims, you want to ensure you’re prepared to demonstrate the validity of each claim with data backed by scientific research. For each color used in the manufacture of products sold in the United States, they will be checked for U.S. certification regardless of their acceptability in other countries. 

Product Sampling

Another possible action taken by FDA is the requirement of a sample of your product. They will take each sample they collect to their laboratory to both identity and confirm safety before releasing the products for sale. Failure to pass may lead to further actions such as recalls or destroying the product.

More Examples of FDA Actions and Notices

The FDA sends out various notices alongside, and after, a general notice of FDA action. Some point to escalation of consequences, others are intended to inform the public. Understanding each will help you navigate the process of getting your product back into the U.S. market.

FDA Warning Letters

In general, a warning letter identifies a specific violation, such as poor manufacturing practices, issues with claims about what a product can do, or even incorrect directions for products intended use. 

If given a FDA warning letter, it will not only make it very clear that the company must correct the problem, but it will also provide both essential directions and a timeframe to inform FDA of your company’s correction plans.

FDA Import Alerts

FDA uses import alerts to notify field staff and the general public that the agency has found enough violative evidence to hold product in detention without physical examination (DWPE). These violations could be related to the product itself, the manufacturer, a specific shipper, or as it concerns other information.  

Import alerts help prevent potentially violative products from being distributed in the United States and help redirect agency resources to examine other questionable shipments. 

These alerts also provide uniform coverage across the country and place responsibility back on the importer, ensuring that the products being imported into the United States are in compliance.

FDA Drug Recalls

A drug recall is normally a voluntary action that companies can take to remove defective drug products from the U.S. market, but can also be required by FDA. It is the most effective way the agency can protect the public from a defective or potentially harmful product.

If FDA deems the recalled product to be widely distributed or has a substantial health risk, the agency may also alert the public if the company in question doesn’t notify the public and remains silent on the matter. 

FDA Detention & Hearing

If an imported product violates imposed regulations, the importer, owner or consignee will receive a notice of detention and hearing.

It lists a timed window called a “respond by date” that allows you to contest the detention by providing FDA with evidence — also called a “testimony” — to overturn the supposed violations. Each violation will also be listed as charges pointing to the laws and regulations in question. 

FDA Medical Device Safety Communications

To describe FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management, FDA posts Medical Device Safety Communications.

Generally, these communications inform the public about a possible risk or action that needs to be taken for a medical device. Though, these communications do not always mean the product in question is unsafe. 

How to Respond to a Notice of FDA Action

Receiving a notice of FDA action can have serious consequences for a company’s reputation and revenue. It is essential to maintain regular communication with your U.S. Agent, as they can serve as a quick and reliable channel of information between your company and the FDA.

An FDA Notice of Action will specify entry numbers, items in question, and will alert the filer, importer, owner and/or the consignee on record as to why the product is being held. 

After receiving a notification, it is necessary to send a reply containing the required details via FDA’s Import Trade Auxiliary Communication System (ITACS). Alternatively, you can submit through the local FDA Import office. In either case, you will be asked to include the following information for each line item requested: 

  • The entry number 
  • The contact information and name of the submitter
  • The entire address for the location of the product in question 
  • The name and phone number for that location’s point of contact 
  • The storage or warehouse lot number, if applicable 
  • The warehouse’s operating hours, if known 
  • Any and all additional documents requested by FDA

Unfortunately, there isn’t a specific timeline for when FDA will complete the examination and sampling. However, your overall compliance with providing requested information in a timely manner will help make the process a far quicker and smoother affair.

Ensuring products are manufactured, packaged, labeled, transported and held in accordance with cGMPs — before receiving a notice of FDA action — will make it even easier, if not help avoid NOAs in the first place.

Best Practices for Addressing FDA Notices

When you receive a notice of FDA action, it’s imperative that you do everything you can to respond promptly and in detail with the requested information. Failure to respond in an adequate or timely manner can result in even harsher enforcement actions, such as injunctions or even product seizures. 

If you’re unsure of how to respond effectively, you may need the assistance of an experienced regulatory specialist. They can help you understand the nature of the concerns raised by the FDA and develop a strategic plan to address them. 

Proactive Compliance Strategies

When you incorporate proactive compliance, both management and employees gain greater knowledge and understanding of the laws and regulations affecting their operations. 

When you employ proactive compliance strategies, you start thinking ahead and controlling both risks and results, identifying and addressing potential issues before violations arise.

Developing a Corrective Action Plan

Another best practice to help prevent and deal with detentions, is creating a corrective and preventive action plan.

These plans list out your steps for collection and analysis of information, the identification and investigation of product and quality problems, and details the appropriate and effective corrective or preventive action to safeguard against their recurrence. 

Seeking Regulatory Expertise From Registrar Corp

A notice of FDA action can be alarming, but in most cases it can be resolved without further action being taken against your business. How long it takes to resolve depends on how thorough your documentation or the knowledge and experience of your U.S. Agent.

Without the proper guidance, it is all too easy to submit inadequate or inaccurate responses and have your product seized, destroyed, or forced into a recall. 

Registrar Corp’s regulatory specialists have helped over 50,000 clients worldwide achieve and maintain compliance with the FDA, keeping products moving freely and out of detention.

Discover how we can give you peace of mind and help you to both prevent and navigate a notice of FDA action and get your product out of detention

Don’t wait! Renew your
FDA registration today.

Registrar Corp will help you re-register with FDA quickly and properly.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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