FDA Facility Registration Certificate – Required for U.S. Market Entry
If your facility manufactures, processes, packs, or holds dietary supplements for sale in the United States, FDA Facility Registration is required under 21 CFR Part 1, Subpart H.
Who Needs It?
- • Domestic Facilities – Must register with the FDA before operations begin.
• Foreign Facilities – Must register and appoint a qualified U.S. Agent for FDA communications.
When Is Registration Required?
- Before any product is manufactured or shipped to the U.S. An unregistered facility risks border holds, refused entry, or enforcement actions.
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
Pricing:
| Service | Standard Price | Support360 Member Price (50% Off) |
|---|---|---|
| FDA Facility Registration (Domestic) | $750 | $375 |
| FDA Facility Registration + U.S. Agent (Foreign - New) | $750 | $375 |
| FDA Registration Renewal + U.S. Agent (Foreign) | $350 | $175 |
- Members of our Support360 Program enjoy 50% OFF on all registration and compliance services.
Why Compliance Matters:
- Failure to register your facility could lead to:
- • Refused shipments at U.S. ports
• Delayed product launches
• Loss of trust from retailers and partners
