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Current as of January 02, 2025 | Updated by Findlaw Staff
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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.207.25 What information is required for registration? - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-207-25/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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