CHALLENGE

Inaccurate monitoring that exposed client to costly penalties and missing suppliers

As part of an FSVP, importers must monitor all their suppliers and their facilities to ensure compliance with FDA. Without proper monitoring, this U.S. importer was at risk of paying detention charges averaging $3,000 higher for shipments coming through U.S. ports than the rest of the world. They were also unknowingly making these mistakes: 

  • Monitoring 2 supplier offices instead of production facilities
  • Missing 12 suppliers from their FSVP 
  • Exposing themselves to risk including failed inspections, warning letters, and costly detentions
Two business owners, one man and one woman, checking inventory of imported goods in warehouse.
Shot of smiling young man responding to client regulatory call next to a row of his colleagues.

SOLUTION

Employing Registrar Corp’s technology and regulatory specialist team

By utilizing Registrar Corp’s tech-enabled services and ComplyHub solution, this importer was able to save time and money while avoiding costly penalties for non-compliance. Specifically, Registrar Corp helped: 

  • Save significant business hours by automating supplier data from the past 24 months 
  • Introduce client to our records management features —giving them access to our AI-powered document templates, automated deadline reminders, and more
  • Avoid detentions by partnering with Registrar Corp’s regulatory specialists with 20+ years of experience 

IMPACT

COSTS SAVED

$57,000

Saved yearly in labor to automate and maintain compliance 

SUPPLIERS FOUND

12

Allowing for full FSVP compliance 

FEES AVOIDED

$7,500

In detention fines saved by complying with FSVP 

Stay FDA compliant 24/7

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