For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities must renew their establishment registration and update product listings to remain in good standing with the FDA. In addition, regulatory requirements are frequently updated, requiring businesses to stay informed and adaptable.

At XPRO AMERICA, we specialize in annual and ongoing compliance management to ensure that your organization remains fully aligned with FDA regulations year after year.

Key Services

• Establishment Registration Renewal:
  FDA requires all U.S. and foreign facilities engaged in the production, repacking, relabeling, or import of regulated products to renew their registration annually. We manage the process seamlessly, preventing lapses that can result in penalties or import refusal.
• Device Listing Updates:
  Every marketed device must be listed with the FDA under 21 CFR Part 807. Our team ensures that all additions, discontinuations, or modifications to your product portfolio are promptly updated in the FDA database.
• Continuous Regulatory Monitoring:
  The FDA frequently issues new rules, safety alerts, and guidance documents. We provide ongoing monitoring and timely updates so your company can adapt proactively instead of reacting to compliance challenges.

Why Ongoing Compliance Matters

Failure to maintain updated registration or product listings can lead to serious business risks, including:

• Import detention or refusal by U.S. Customs.
• Delays in product launches or distribution.
• Warning letters and enforcement actions from the FDA.
• Loss of consumer trust and market access.

With XPRO AMERICA’s proactive compliance support, businesses can avoid these risks and focus on growth.

Why Choose XPRO AMERICA?

• Expert Guidance: Specialized in FDA compliance across multiple industries, including medical devices, pharmaceuticals, dietary supplements, and cosmetics.
• Timely Renewals: Ensuring no lapses in registration or product listing.
• Regulatory Intelligence: Continuous tracking of FDA updates for early compliance readiness.
• Global Support: Assistance for both U.S. and foreign manufacturers accessing the American market.

By partnering with XPRO AMERICA, companies gain peace of mind knowing their annual compliance requirements are handled efficiently and accurately.

XPRO AMERICA ensures FDA annual registration renewal, device listing updates, and monitoring of regulatory changes for continuous compliance.