Get Form Fda 3356. Establishment Registration And Listing For Human Cells

Step by Step instruction to search Drug establishment registration number. Click on the below link. https://.accessdata.fda.gov/scripts/cder/drls/getdrls.cfm. Enter the company name in query box. ... After you perform search action , name of the establishment, address and validity of the registration will appear.

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).

(c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.

The drug establishments current registration site is a publication of currently registered establishments which manufacture, prepare, propagate, compound or process drugs that are distributed in the U.S. or offered for import to the U.S. This file is updated each business day.

Food. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Under the Bioterrorism Act of 2003, all warehouse facilities that store or handle products intended for consumption by humans or animals in the United States are required to register with the U.S. Food and Drug Administration (FDA).

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products.

Electronic Human Cell and Tissue Establishment Registration (eHCTERS) provides access to the establishment registration form (Form FDA 3356), instructions for completing (paper and electronic form), and other information on the Electronic Human Cell and Tissue Establishment Registration (eHCTERS).