The answer depends on geography. If the same company’s two locations manufacture a U.S. generic product and they are in different geographic locations, each has to pay an annual facility fee. However, separate buildings within close proximity are considered to be at one geographic location or address if:
(1) The activities in them are closely related to the same business enterprise;
(2) They are under the supervision of the same local management; 5 and
(3) They are capable of being inspected by FDA during a single inspection
These are the same criteria used to evaluate whether separate facility establishment identifiers (FEIs) are necessary for multiple facilities.
