: A Step-by-Step Guide
Navigating the FDA MoCRA facility registration process can seem daunting, but with the right guidance, it becomes much simpler. At FDC Corp., we’ve compiled a detailed guide based on common inquiries and FDA’s official requirements to help you streamline the process. Whether you’re a domestic or international business, this step-by-step breakdown will ensure you’re well-prepared for compliance.
Step 1: Obtain a DUNS Number
The first step in facility registration is obtaining a DUNS (Data Universal Numbering System) number, which serves as a unique identifier for your business. Here’s how you can secure one:
- Visit the Dun & Bradstreet website to apply for a DUNS number.
- Ensure your business registration certificate is translated into English and ready for submission.
- The application process is straightforward and often free of charge.
Having a DUNS number is essential, as it links your facility to official records and is required for FDA registration.
Step 2: Apply for an FEI Number and Register Your Facility
Once you’ve obtained your DUNS number, the next step is to request an FEI (Facility Establishment Identifier) number from the FDA. This number is critical for facility identification and registration. Here’s what the process involves:
- Submit detailed information about your facility, including company name, address, and the type of activities conducted at the location.
- For facilities based outside the U.S., appointing a US Agent is mandatory to complete the registration process via FDA Direct. The US Agent acts as a communication liaison between your facility and the FDA.
Estimated Timeline
Facility registration typically follows this timeline:
- DUNS and FEI Numbers: These are usually issued within four business days of application.
- Facility Registration: The entire process, including document preparation and communication with agents, takes approximately seven days.
Keep in mind that additional time may be required if there are delays in document submission or coordination with your US Agent.
US Agent Services: Simplifying the Process
For non-U.S. facilities, appointing a US Agent is a crucial step in the registration process. At FDC Corp., we offer comprehensive US Agent services to ensure accurate and efficient registration. With over 30 years of expertise in FDA compliance, we specialize in helping businesses secure long-term export stability and regulatory adherence.
Our team handles the complexities of FDA facility registration so you can focus on growing your business. Whether you need assistance with acquiring a DUNS number, applying for an FEI number, or appointing a US Agent, we’re here to guide you every step of the way.
Contact Us Today
Don’t let the registration process slow down your export strategies. Contact FDC Corp. today to simplify your FDA MoCRA registration and ensure your facility complies with all regulatory requirements. Trust us to deliver efficiency, accuracy, and peace of mind for your business.
