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
607.21Times for establishment registration and blood product listing.#
The owner or operator of an establishment entering into an operation defined in § 607.3(d) shall register such establishment within 5 days after the beginning of such operation and submit a list of every blood product in commercial distribution at the time. If the owner or operator of the establishment has not previously entered into such operation (defined in § 607.3(d) of this chapter) for which a license is required, registration shall follow within 5 days after the submission of a biologics license application in order to manufacture blood products. Owners or operators of all establishments so engaged must register annually between October 1 and December 31 and must update their blood product listing every June and December.
United States Government work; public domain under 17 U.S.C. § 105.