21CFR207.25

Registrants must provide the following information: (a) Name of the owner or operator of each establishment; if a partnership, the name of each partner; if a corporation, the name of each corporate officer and director, and the place of incorporation; (b) Each establishment's name, physical address, and telephone number(s); (c) All name(s) of the establishment, including names under which the establishment conducts business or names by which the establishment is known; (d) Registration number of each establishment, if previously assigned by FDA; (e) A Unique Facility Identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act. (f) All types of operations performed at each establishment; (g) Name, mailing address, telephone number, and email address of the official contact for the establishment, as provided in § 207.69(a) ; and (h) Additionally, with respect to foreign establishments subject to registration, the name, mailing address, telephone number, and email address must be provided for: (1) The United States agent, as provided in § 207.69(b) ; (2) Each importer in the United States of drugs manufactured, repacked, relabeled, or salvaged at the establishment that is known to the establishment; and (3) Each person who imports or offers for import such drug to the United States.