Importance of FDA Registration Renewal
Renewing your FDA registration is essential for maintaining compliance with U.S. regulations. Every facility that manufactures, processes, packs, or stores food, medical devices, or pharmaceuticals for U.S. distribution must renew its registration to stay active in the FDA database. Failure to renew may lead to suspension or cancellation, halting product imports or sales. This process ensures the FDA has updated information about your facility and its operations.
When to Renew Your FDA Registration
FDA registration renewal typically occurs how to renew FDA registration even-numbered year between October 1 and December 31. Businesses must act within this window to avoid penalties. The renewal requirement applies to both U.S. and foreign facilities. Missing the renewal deadline can cause your registration to be automatically canceled, requiring you to submit a new registration before resuming operations.
Step-by-Step Renewal Process
To renew, log in to the FDA Industry Systems (FIS) portal using your account credentials. Review all facility information, ensuring details like owner name, address, and contact information are correct. Confirm your U.S. Agent details if you’re an international facility. Once verified, submit the renewal electronically and keep a copy of your confirmation for records.
Common Mistakes to Avoid
Many companies fail to update essential details during renewal, leading to inaccurate records or rejected renewals. Ensure the correct DUNS number and contact information are entered. Avoid delays by preparing your documents ahead of time and verifying data accuracy before submission.
Why Professional Assistance Helps
While renewal can be done independently, using professional FDA registration services can streamline the process. Experts help avoid errors, ensure timely submission, and manage communication with the FDA. This guidance minimizes compliance risks and keeps your facility fully authorized for U.S. operations.