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
Changes in individual ownership, corporate or partnership structure, location, or blood product handling activity must be submitted electronically through the Blood Establishment Registration and Product Listing system, or any future superseding electronic system, as an amendment to registration within 5 calendar days of such changes. Changes in the names of officers and directors of the corporations do not require such amendment but must be shown at time of annual registration.
United States Government work; public domain under 17 U.S.C. § 105.