A small U.S. importer had been in business for just 2 years before receiving a Warning Letter from FDA, leaving them confused by the complexities of addressing the letter and needing support to achieve FSVP compliance. They were faced with a host of challenges, including:  

• A lack of FSMA and FSVP knowledge, with no plan or documentation as a result 
• The potential for the situation to escalate and future products subject to detentions or refusals 
• Significant time taken from growing their business by trying to gain compliance 

After presenting Registrar Corp with their challenges, the importer was able to achieve FSVP compliance and save their growing business.

Specifically, Registrar Corp helped to:  

• Educate the business on FDA requirements and how to manage their FSVP 
• Address the outstanding Warning Letter and avoid costly fines 
• Introduce the ComplyHub platform to efficiently and easily find qualified suppliers