Foreign food, beverage, drug, cosmetic, or medical device companies that want to market their products in the United States must comply with U.S. Food and Drug Administration (FDA) regulations. One of the most critical requirements is the appointment of a U.S. Agent. The FDA mandates that all foreign facilities designate a U.S. Agent who serves as the primary contact point between the company and the FDA for compliance, inspection, and regulatory communication.

The role of the U.S. Agent is far more than a formality. They act as the official representative for handling FDA communications, responding to inquiries, assisting during inspections, and ensuring that time-sensitive regulatory updates are not missed. Since the FDA often operates on strict deadlines, having a reliable and knowledgeable U.S. Agent is essential to avoid costly delays, shipment holds, or compliance penalties.

A U.S. Agent must be available 24/7 to receive communications from the FDA. This includes emergency situations such as recalls, safety notifications, or enforcement actions. Without a designated U.S. Agent, foreign companies cannot successfully complete FDA registrations, including Food Facility Registration, Drug Establishment Registration, or Cosmetic Product Listing.

At XPRO America, we provide professional U.S. Agent services for foreign companies across multiple industries regulated by the FDA. Our experts are available round-the-clock to respond promptly to FDA inquiries, ensuring that your business remains compliant and uninterrupted. We also assist with facility registrations, renewals, product listings, and ongoing compliance consulting.

By appointing XPRO America as your U.S. Agent, you gain a trusted partner who understands FDA regulations and represents your facility with accuracy and professionalism. This allows you to focus on expanding your business in the U.S. market with complete confidence that your FDA communications are being handled efficiently.

For every foreign manufacturer or distributor, appointing a reliable U.S. Agent is not just a requirement it is a safeguard for business continuity and regulatory compliance.

Appoint XPRO America as your 24/7 US FDA Agent. We handle FDA communications, inspections, and compliance for foreign facilities entering the U.S. market.