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End-of-Year FDA Agent Checklist: What International Companies Must Review Before the New Year

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As the year comes to a close, foreign manufacturers and exporters selling products into the United States should take time to review their FDA compliance status—especially their U.S. FDA Agent designation.

For international companies, an FDA agent is not optional. It is a legal requirement for most FDA-regulated products entering the U.S., including food, dietary supplements, cosmetics, medical devices, and drugs. Failing to maintain an active, responsive FDA agent can result in shipment delays, refusals, warning letters, or import alerts.

This end-of-year checklist will help you confirm that your FDA agent relationship, registrations, and records are accurate and ready for the year ahead.

Why an End-of-Year FDA Agent Review Matters

The FDA expects real-time communication, accurate registration data, and prompt responses to regulatory inquiries. Many compliance issues arise not because companies intend to violate FDA rules—but because contact details, agent agreements, or registrations are outdated.

Common year-end risks include:

  • FDA notices sent to an inactive or unresponsive agent
  • Facility registration lapses or incorrect product categories
  • Corporate changes that were never updated with FDA
  • Assuming a freight forwarder or consultant is acting as your FDA agent (when they are not)

An annual review helps prevent disruptions to U.S. market access.

End-of-Year FDA Agent Checklist for Foreign Companies

1. Confirm Your FDA Agent Is Actively Designated

Verify that your FDA agent is:

  • Officially listed in your FDA facility or establishment registration
  • Authorized in writing to act on your behalf
  • Based in the United States with a physical U.S. address
  • Prepared to respond to FDA inquiries within 24 hours

If your agent relationship ended, changed, or was never formalized, now is the time to correct it.

2. Validate FDA Registration Accuracy

Review all FDA registrations linked to your company and facilities:

  • Company name and legal entity
  • Facility address and contact details
  • Product categories and activities
  • FDA agent contact information

Even small discrepancies can trigger questions during inspections or imports.

3. Check Product Scope and Regulatory Coverage

Many international companies expand their product lines during the year. Confirm that:

  • New products are properly classified under FDA rules
  • Your FDA agent understands all product types you sell
  • Any changes in formulation, labeling, or intended use were assessed for FDA impact

This is especially important for dietary supplements, cosmetics, and medical devices, where classification errors are common.

4. Review FDA Communications from the Past Year

Ask your FDA agent to confirm:

  • Whether any FDA notices, inquiries, or requests were received
  • How those communications were handled
  • Whether any follow-up actions are still pending

If your agent did not proactively share communications, this is a red flag.

5. Prepare for Annual FDA Renewal Deadlines

Certain FDA registrations must be renewed on a fixed schedule:

  • Food Facility Registration: Biennial renewal (even-numbered years)
  • Medical Device Establishment Registration: Annual renewal
  • Drug Establishment Registration: Annual updates

Your FDA agent should track these deadlines and notify you well in advance.

6. Confirm Emergency and After-Hours Coverage

FDA communications do not always arrive during business hours. Ensure your FDA agent:

  • Monitors email and phone consistently
  • Has escalation procedures for urgent FDA matters
  • Can support time-sensitive import issues, detentions, or refusals

Delays of even a few hours can impact shipments.

7. Assess Whether Your FDA Agent Is Still the Right Fit

Not all FDA agents provide the same level of service. Consider:

  • Responsiveness and regulatory experience
  • Familiarity with your product category
  • Transparency in communication
  • Willingness to assist beyond basic message forwarding

An end-of-year review is a good opportunity to upgrade to a dedicated, compliance-focused FDA agent if needed.

Looking Ahead: Start the New Year with Confidence

Maintaining a reliable FDA agent is one of the simplest—but most critical—steps foreign companies can take to protect their U.S. business. An annual review ensures you are not exposed to unnecessary compliance risks as regulations evolve and enforcement continues to increase.

If you are unsure whether your current FDA agent designation is accurate, active, or sufficient, now is the best time to address it—before shipments move in the new year.

Need Help Reviewing Your FDA Agent Status?

Working with an experienced FDA agent who understands international manufacturers can make the difference between smooth imports and costly disruptions. A proactive review today can save time, money, and regulatory headaches tomorrow.

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