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)This part establishes establishment registration and product listing requirements for manufacturers of human blood and blood products.
(b)This part establishes establishment registration and product listing requirements for manufacturers of products that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act and that are licensed under section 351 of the Public Health Service Act, as well as licensed biological products used in the manufacture of a licensed device.
United States Government work; public domain under 17 U.S.C. § 105.