Two masked food safety workers inspect manufactured beverages to ensure FDA compliance and safeguard against these common FDA violations examples.
Author

Fabiola Negron

Director of Food Safety

7 Revenue-Crippling FDA Violations Examples You Should Avoid

Nov 21, 2023

Common U.S. Food and Drug Administration (FDA) violations examples can be found throughout several industries. Though easily avoidable, without the right information on hand, they are just as easy to bring about. Violations can carry with them various consequences and the last thing any business regulated by the FDA wants is to be on the receiving end of a Notice of FDA Action. 

 Violations can be as simple as pest control and personnel issues or more complex in nature like falling short of FSVP and HACCP. In either case, violations can present major setbacks for a business in the form of detentions, demurrage fees, injunctions, and even criminal prosecution. 

The best way to avoid serious consequences to your bottom line is to be aware of these more common FDA violations examples and set systems in place to assure your business doesn’t fall into non-compliance. 

What Does FDA Consider a “Violation?”  

Any product regulated by FDA that is imported for distribution in the United States must comply with all applicable FDA laws and regulations. This includes the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food Safety Modernization Act (FSMA), and other related acts that give FDA authority over various industry regulations.  

If at any time a business fails to achieve compliance with any of the mandates FDA has set forth, they are in violation and may be subject to various enforcement actions. For example, if a business claims FDA Approval, they may find themselves in violation as the Administration prohibits food and beverage companies from doing so.  

The Consequences of These FDA Violations Examples 

FDA has jurisdiction over any FDA-regulated food distributed in interstate commerce. This includes imported foods. 

There are several actions that can be issued by FDA after an unfavorable inspection. In fact, something as non-compliant product labels can be the cause of several violations. 

Here’s a look at some of the compliance actions issued by FDA after an inspection: 

FDA Warning Letters  

FDA issues warning letters to notify firms of significant regulatory violations and provides an opportunity for the firms to take voluntary corrective actions. A firm must respond to an FDA Warning Letter within 15 business days with a list of corrective actions and any supporting evidence to demonstrate compliance. The FDA will then determine if the actions are appropriate to address the issues raised or if further action is needed. 

FDA Warning Letters are made public in FDA’s Data Dashboard. A Warning Letter may remain public even after its status has changed or it has been closed by FDA. Furthermore, FDA Warning Letters are not required prior to FDA issuing enforcement action. 

Seizures of Products  

Simply put, a product seizure is brought against an FDA-regulated product when it is found to be adulterated or misbranded within the context of the FD&C Act.  

Seizures are intended to remove products from the U.S. market and place them under the custody of the courts until the court determines if they are violative as alleged.  

This can come as a serious blow to a business’s bottom line as court fees, market delays, and other consequences begin stacking up due to something as simple as a labeling error causing FDA to deem your product misbranded.  

Consent Decrees and Injunctions  

An injunction can either be permanent or temporary in nature. Injunctions are court orders that require a defendant to either perform an act in which they are already obligated by law, or forbids the defendant from doing a specific act they are attempting to do.  

If deemed necessary, FDA will request that the courts grant an injunction to halt or prevent violation of their regulatory mandates. For example, the Administration can set forth an injunction to prevent products from entering the U.S. market and to force correction of the violation in question. 

When an injunction is granted, if a defendant fails to obey the terms of the consent decree, FDA may escalate the issue by initiating civil or criminal contempt proceedings or other regulatory actions. 

Criminal Prosecution  

Worst of all, if a business finds itself in violation and continues to do so after receiving a court ordered injunction due to intentional disregard or simply repeated mistakes in compliance, they will find themselves on the receiving end of criminal prosecution. 

If an injunction is not followed, FDA’s Office of Criminal Investigation will examine any violative activities concerning FDA-regulated products. They will arrest those responsible and bring them before the U.S. Department of Justice for prosecution.  

This can result in hefty fines, debarment, import bans, and even imprisonment. Not only does this affect business in the United States, but such actions earn public attention and may cause a greater loss of long-term revenue throughout the global market and supply chain.  

The 7 Most Common FDA Violations Examples 

Not all FDA violations are major actions that have been taken or neglected. Some can be small and easy to miss: the wrong ingredient on a label, too many flies buzzing around production lines, or personnel failing to wash their hands during an inspection. 

Regardless of how major the violation, they can all be equally damaging if not taken care of. That’s why it’s best to understand the requirements and what FDA commonly lists as a violation and prepare your business in advance. 

Here are the top 7 violations FDA commonly cites: 

1. Pest Control 

A common issue in the food and beverage industry, pest control violations often arise due to insanitary conditions and insufficient measures to exclude them from the food processing, packing or holding areas.  

Whether it’s an excess of flies in summer, or rats and other pests in storage, food safety is impacted by their presence and FDA will consider your business in violation for their presence.  

2. Manufacturing Controls

Failure to follow standard operating procedures for manufacturing is one of the more common violations, however, most of these violations are negligent, rather than intentional.  

The vast majority of violations in this category revolve around Current Good Manufacturing Practice (cGMPs). They can include anything from a lack of fall protection and hazard communication to failure to provide controlled environments for food handling.  

3. Hazard Analysis 

FDA requires most facilities to identify potential biological, chemical or physical hazards that may occur and to establish preventive controls as applicable for significant hazards.  

For example, a facility can identify areas where inadequate cleaning of equipment may cause cross-contamination. Failure to properly identify these hazards and detail appropriate methods to resolve prevent or control the issues will lead to this common violation. 

4. Sanitary Operations 

Rather than from various industry horror stories that lead to mass recalls or public health alerts, many of these violations arise from all too common and less headline-worthy reasons.   

These can include failure to properly monitor the safety of water that comes into contact with food, the condition and cleanliness of food contact surfaces, or even a lack of maintenance in hand washing and toilet areas.

5. FSVP Violations

During Foreign Supplier Verification Program (FSVP) inspections, FDA requires food importers to present complete FSVPs that demonstrate a suppliers’ food safety compliance. More often than not, these violations arise due to simply not having an FSVP plan developed which has been the #1 observation sinve FSVP has been enforced. 

6. HACCP Plan Implementation

Just as with FSVP, a common mistake that leads to this violation is simply not having a HACCP Plan developed or in place by the time an inspection happens. This HACCP Plan requirement applies to seafood and juice processors. Other common inspection violations include failure to adhere to the plan in general.

7. Personnel

Personnel violations can hit any industry and doesn’t only affect food safety. Any industry that requires sanitation concerning the production team can earn FDA violation.  

Whether it’s the lack of use of personal protective equipment, or simply poor hygiene in the form of handwashing and hair nets, these violations are among the easiest to earn. 

How to Avoid These Common FDA Violations Examples  

Enforcement Actions for FDA violations can vary in severity, but when a business continues to violate regulatory compliance mandates — no matter how small — greater action will be taken that can critically affect business.  

Attempting to navigate FDA regulations on your own is certainly an option, though if you’re unfamiliar with the compliance landscape for your industry it can be a difficult and risky endeavor. 

You can easily avoid these damaging violations and achieve full regulatory compliance by leveraging our 20 years of experience in the industry.  

Registrar Corp has spent the last two decades helping over 30,000 companies each year across 190+ countries navigate the complexities of FDA compliance. We can help you, too. 

Discover how we make FDA compliance quick and easy and avoid the pitfalls of these common FDA violations examples. 

Author


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

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