After being issued a Warning Letter, a U.S. food importer was concerned about significant business repercussions and needed support. They had unknowingly misidentified their suppliers. As a result, their FSVP plan was noncompliant. With only 15 days to respond to FDA (or risk their shipments being detained), they needed to: 

• Uncover why they were responsible for a supplier they didn’t know they had 
• Properly identify any suppliers and update their FSVP plan accordingly 
• Respond properly to the warning letter to avoid fines and detention at port 
• Introduce proactive measures to prevent this from happening in the future 

Through a combination of expert education and automated technology, Registrar Corp not only solved this importer’s immediate issues, but set them up for future success—avoiding costly fines and keeping their supply chain healthy. Specifically, Registrar Corp helped to: 

• Explain the consequences of FSVP non-compliance at the FDA Warning Letter stage 
• Provide access to our ComplyHub platform and its supplier tracking features, uncovering data they were obligated to track under FSMA 
• Identify that they had been working with 90+ additional suppliers under an international distributor
• Address the Warning Letter and avoid significant business delays and losses