607.25—Information required for establishment registration and blood product listing.
(a)
Form FD-2830 (Blood Establishment Registration and Product Listing) requires furnishing or confirming registration information required by the act. This information includes the name and street address of the establishment, including post office code; all trade names used by the establishment; the kind of ownership or operation (that is, individually owned partnership, or corporation); and the name of the owner or operator of such establishment. The term “name of the owner or operator” shall include in the case of a partnership the name of each partner, and in the case of a corporation the name and title of each corporate officer and director and the name of the State of incorporation. The information required shall be given separately for each establishment, as defined in § 607.3(c).
(b)
Form FD-2830 also requires furnishing blood product listing information required by the act as follows:
(1)
A list of blood products, including bulk product substances as well as finished dosage forms, by established name as defined in section 502(e) of the act and by proprietary name, which are being manufactured for commercial distribution and which have not been included in any list previously submitted on Form FD-2830 (Blood Establishment Registration and Product Listing) or Form FD-2250 (National Drug Code Directory Input).
(2)
For each blood product so listed which is subject to section 351 of the Public Health Service Act, the license number of the manufacturer issued by the Center for Biologics Evaluation and Research, Food and Drug Administration.
(3)
For each blood product listed, the registration number of the parent establishment. An establishment not owned, operated, or controlled by another firm or establishment is its own parent establishment.