FDA Registered Food Facilities are required to provide a Unique Facility Identifier (UFI) recognized as acceptable. Currently, the only UFI recognized by the U.S. Food and Drug Administration is the Data Universal Numbering System (DUNS) Number.
Therefore, failure to update the registration with an accurate DUNS number in accordance with 21 CFR 1.230(b) before September 15, 2023, will result in Cancellation of the Registration.
OTC (Over-the-Counter) drugs may be marketed without an approved application under section 505 of the FD&C Act if they meet the requirements of section 505G of the FD&C Act, including applicable conditions in an OTC Monograph.
Also, keep in mind that the U. S. Food and Drug Administration has increased the number of foreign site inspections in recent years, by posting staff in certain overseas regions.
So, be prepared.