Initial Importer

Vital Compliance > Initial Importer

Initial Importer

FDA regulations require an initial importer to be an establishment with a physical address in the US. It needs to be a place of business that the FDA can visit and inspect. An initial importer needs to register with the FDA, pay the annual registration fee, and maintain detailed operating procedures. The reason for these requirements is that the FDA wants a US establishment to be responsible for reporting and managing adverse events and recalls.

For a foreign manufacturer, it can become a real struggle to find distributors that are registered with the FDA as an initial importer. Most distributors do not want to take on legal responsibility for compliance, pay the annual registration fee, operate in strict compliance with operating procedures, and host FDA inspections. The ideal solution is to identify an independent company that specializes in serving the role as an initial importer. Fortunately, that is exactly what we at Vital Compliance have years of experience in.

Vital Compliance is not just another initial importer; we are your partner throughout every step of the process. Unlike Vital Compliance, most initial importers will not be there for you on weekends or during US holidays when you may need their assistance most.

We are willing to make these sacrifices because we understand the importance of addressing our client’s immediate concerns. We are going be there to help you with the importation process and assist you in understanding what is required by Customs and the FDA so that things will go smoothly.

To learn more please contact us at

Vital Compliance FDA Furls Database Data Entry

US Agent Services

We have years of experience serving as US Agent to foreign establishments and are committed to providing first in class service to our customers.

Facility Registration

Whether you have a single facility or multiple facilities to register with the FDA we are here to help walk you through the entire process.

FDA Furls Data Entry Services

We offer product registration services to our customers. Whether it is a single product or thousands, we will get the job done.

Initial Importer Services

We act as an initial importer, maintain quality system procedures, and ensure a smooth approval process through US customs.