Registrar Corp has added U.S. Food and Drug Administration (FDA) registration numbers to its FDA Compliance Monitor. In an effort to prevent delays and detentions, users can now verify their suppliers’ registration status prior to import.
Food, drug, and medical device establishments are required to register with FDA before selling their products in the United States. After successfully registering, facilities are assigned a unique FDA registration number. These numbers can abruptly become invalid if the registration is not properly updated after a change of ownership, the registration was not submitted by an authorized person, the facility U.S. Agent does not accept the designation, or the facility’s registration is not properly renewed prior to an FDA registration renewal deadline. Invalid registrations can cause delays or detentions at the port of entry.
Monitoring Food Facility Registrations
Food facilities must renew their registrations between October and December of every even numbered year. Following this period, FDA removes all non-renewed registrations from its database. In 2019, 20% of FDA food facility registrations were removed from FDA’s database.
Food facility registration numbers are not publically available, making this new feature an unprecedented opportunity for food importers. Immediate access to all of your suppliers’ registration numbers in one place is valuable for filing Prior Notice and verifying supplier compliance with FDA registration requirements. Knowing if your supplier’s registration number is invalid ahead of time can be invaluable for importers and can help avoid costly demurrage charges.
Monitoring Medical Device and Drug Establishment Registrations
FDA requires medical device and drug establishments to register between October and December of every year. Establishments not renewed as required by FDA are removed from their database. The most recent removal saw the total number of medical device registrations fall by 9%. Products from medical device or drug establishments without valid registrations may be detained or even refused at port, which can cause delays that may affect the purchasing decisions of importers.
In order to know if a registration is still valid, one would have to check FDA’s medical device and drug establishment registration database for each individual supplier every time they intended to receive a shipment. The Monitor eliminates this hassle by allowing users to quickly and easily verify their suppliers’ registration numbers in one place. The Monitor continuously tracks the status of registration numbers and automatically alerts users if a registration becomes invalid, allowing both facilities and their importers to proactively resolve non-compliance before issues occur in port.
About the Monitor
Registrar Corp developed the FDA Compliance Monitor to assist companies with supply-chain monitoring requirements under FDA’s Preventive Controls and Foreign Supplier Verification Program (FSVP) rules. The Monitor aggregates and supplements data from five FDA databases to supply comprehensive, up-to-date compliance reports on all FDA-regulated companies. Businesses can easily monitor:
- FDA Registration Numbers
- FDA Inspection Classifications
- Warning Letters
- Import Alerts
- Import Refusals
Registration numbers are simply one component of a plan to further strengthen the Monitor as a comprehensive supply-chain management solution. Future updates include a repository for requesting and storing documentation of supplier compliance as well as enterprise integration capabilities.
To learn more about how Registrar Corp’s FDA Compliance Monitor can help simplify compliance with FDA supplier monitoring requirements, schedule a 1-on-1 demo today or call us at +1-757-224-0177.