Foreign companies manufacturing, repackaging, relabeling, or importing FDA-regulated products into the United States are required to appoint a U.S. Agent. The U.S. Agent serves as the official liaison between the company and the FDA, ensuring that regulatory communications, inspection notices, and emergency matters are handled efficiently and accurately.

At XPRO AMERICA, we offer professional U.S. Agent services to help foreign manufacturers maintain compliance, respond to FDA inquiries, and facilitate smooth market entry in the United States.

Key Services:

• Mandatory U.S. Agent Appointment: Foreign facilities must designate a U.S. Agent to meet FDA regulatory requirements. XPRO AMERICA acts as your official FDA point of contact, ensuring all correspondence is properly received and addressed.
• FDA Communication Management: Our team handles all communications from the FDA, including routine correspondence, inspection scheduling, and requests for additional information, ensuring timely and accurate responses.
• Inspection Notices & Support: The U.S. Agent receives inspection notifications on behalf of the foreign facility. We assist in coordinating inspection logistics, documentation, and pre-inspection preparation to ensure compliance readiness.
• Emergency Response Coordination: In the event of FDA enforcement actions, product holds, recalls, or compliance issues, XPRO AMERICA provides rapid communication and guidance to resolve regulatory matters efficiently.
• Regulatory Guidance & Compliance Monitoring: Beyond acting as a liaison, we advise on FDA regulations, updates, and ongoing compliance requirements, helping foreign manufacturers maintain regulatory confidence.

Why Choose XPRO AMERICA?

• Experienced in managing FDA communications for foreign facilities across multiple product categories.
• 24/7 availability to respond to inspections, enforcement notices, and emergencies.
• Minimizes risk of non-compliance and potential delays in product marketing.
• Ensures continuous alignment with FDA expectations and regulatory changes.

Partnering with XPRO AMERICA as your U.S. Agent ensures that foreign manufacturers are fully compliant with FDA requirements. Our services facilitate smooth communication, regulatory readiness, and prompt resolution of issues, supporting uninterrupted operations and market access in the United States.

XPRO AMERICA provides mandatory U.S. Agent services for foreign manufacturers, managing FDA communications, inspections, and emergency responses.