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§207.25. What information is required for registration?

21 C.F.R. § 207.25

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.
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.

Source

Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.