refers to an establishment that is located in a foreign country and is the site where a blood product that is imported or offered for import into the United States was manufactured.
us/cfr/21/607
Key facts
Type
CFR part · 21 CFR Part 607
Made by
Chapter I—Food and Drug Administration, Department of Health and Human Services
(a)In addition to the information routinely required by §§ 607.25 and 607.30, the Director of the Center for Biologics Evaluation and Research may require submission of the following information by letter or by Federal Register notice:
(1)For a particular blood product so listed, upon request made by the Director of the Center for Biologics Evaluation and Research for good cause, a copy of all advertisements.
(2)For a particular blood product so listed, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a quantitative listing of all ingredients.
(3)For each registrant, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a list of each listed blood product containing a particular ingredient.
(b)[Reserved]
United States Government work; public domain under 17 U.S.C. § 105.