fda consulting

Has your facility recently received a notice from the Food and Drug Administration in response to a facility inspection? No matter the regulatory action your business faces, we have practical solutions. Food safety is an essential expense to your food business, but it doesn’t have to put you out of business. 

What makes us different? 

Many consultants and firms have programs and processes that drastically cut into a food company's bottom line making it impossible to make a profit. Our consultants are scientists that understand business! We care about the needs of the consumer and the business owner. 

Food companies facing regulatory action should research potential FDA consultants to ensure they possess the relevant skills and experience to achieve successful results. Many consultant firms are known to operate like an assembly line outsourcing their work to less qualified consultants. These firms provide their subcontracted consultants with generic templates, decision flow charts, and company scripts in place of specialized client attention and tailormade solutions. 

Our consultants are highly trained, qualified industry experts with a proven track record of success in FDA regulated industries. We work with businesses of all sizes ranging from small startups to mid-size firms and we understand the business constraints that are faced at various stages of growth. Our priority is finding practical and feasible solutions for our clients to attain regulatory compliance without unnecessarily cutting into the bottom line. 

What makes us the most qualified to do the job? 

Our consultants have firsthand experience dealing with Federal regulators and have proven solutions that have been accepted by the FDA. We have experience interacting with compliance officers, investigators, auditors, and regulators in many sectors of the government. We have successfully assisted clients with inspections, enforcements, depositions, and more. 

Call us today to discuss your FDA Consulting needs. We will evaluate your current situation and determine your needs for compliance, develop a tailored solution that is practical for your business, and respond to your company's regulatory action notice. 

If you have received an enforcement such as Form 483 or a Warning Letter, we will assist you in prompt resolution with the government. 

 
Bottom-line - you don't want to be on the wrong side of the Feds! 

Received a Regulatory Enforcement Action - Form 483, Warning Letter, Citations? 

The FDA conducts routine facility inspections of food facilities registered with the FDA. Food facilities are selected at random for inspection. The FDA also conducts inspections in response to complaints, recall investigations or findings during inspections of food facilities your company does business with. 

If a food facility is selling food to the public without FDA compliance, there are several possible enforcements actions:

• Citation
• Form 483
• Warning Letter
• Injunction
• Criminal penalties

If you have received an enforcement action from the FDA it is crucial your company responds within the assigned deadline to avoid escalations and additional enforcement actions. If your company has received an action, call us today to determine the solution for prompt resolution with the government. 

What happens if I do not respond to the regulatory notice?

The regulatory enforcement notice will clearly state the deadline for response. Typically, a food company has 15 days to respond. Failure to respond will result in additional escalations and enforcements up to injunction. In some cases, criminal penalties could apply.  

At minimum, a business owner must respond to the letter regardless of hiring a consultant to avoid additional costly escalations. We would highly caution against this action as speaking to Federal regulators is like speaking to the police; anything you say can and will be used against you. Comments a layperson would find harmless could trigger additional citations or prodding questions from a regulator.  

Call us today and we will ensure an appropriate, expert developed remediation plan for your regulatory enforcement action to ensure prompt resolution with the government!