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.
607.7Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.#
All owners or operators of establishments that engage in the manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act. Registration and listing of blood products must comply with this part. Registration does not permit any blood bank or similar establishment to ship blood products in interstate commerce.
United States Government work; public domain under 17 U.S.C. § 105.
Key facts
Type
CFR part · 21 CFR Part 607
Made by
Chapter I—Food and Drug Administration, Department of Health and Human Services