FDA Registration Renewal
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FDA Approval and Certification
Renewing an FDA registration
An FDA registration is renewed through the FDA Electronic Submissions Gateway (ESG). The original firm record is resubmitted under the same identifier in SPL format. A registration is valid through 31 December of the following year, and both domestic and foreign establishments that are registered with the FDA must renew their record each year between 1 October and 31 December.
What stays the same, what must be updated
After renewal, the FDA registration number and the facility identifier remain the same. A pharmaceutical manufacturer must keep at least one drug on its FDA listing to maintain the registration. A company that misses the 31 December deadline risks FDA import refusals, regulatory actions, or detention of foreign-manufactured goods at the port of entry.
Cosmetic companies and OTC product lines, including sunscreens, antibacterial hand sanitisers, and acne treatments, must also renew their registrations annually. A company that wants to stop marketing in the US and cancel its registration must send a de-registration notice to the FDA through SPL.
What Sistem Patent Kalite covers
Sistem Patent Kalite handles the renewal filing through ESG, keeps the client record active, and flags any changes to the FDA profile that need to be reflected in the submission. Clients avoid missed windows and sudden port detentions by letting the consultancy track the annual renewal.
