Who needs FDA Establishment Registration?

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.

Do I have to register my facility with the FDA?

If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA, unless you are exempt under 21 CFR 1.226 from the requirement to register …

What is an FDA establishment number?

The US FDA will assign a unique registration number to each registered food facility, the assignment of FDA registration number does not denote the approval of your establishment or product by the US FDA. The FDA registration number only recognizes that, your establishment is registered with US FDA.

How long does FDA Establishment Registration take?

A: It may take up to 90 calendar days for the FDA to assign a registration number to a facility. During this time, a facility can use its owner/operator number and device listing number (if applicable) to import its medical devices into the United States until the FDA assigns a registration number.

Why have establishment registration and device listing requirements?

Registration and listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

What is FDA establishment identifier?

1. What is an FDA Establishment Identification number? An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track GDUFA facility fee payments.

How do I find my FDA number?

The public is advised to always check if a food product or food supplement is registered with the FDA by using the FDA Verification Portal feature accessible at https://verification.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or simply type the name of the product.

How do you register with the FDA?

If you are a manufacturer or initial distributor/importer of medical devices, you are required to register your establishment with the FDA. Log on to FURLS (FDA Unified Registration and Listing System) to register and list your information. An owner or operator must have an account ID and password to access FURLS.

Who must register with the FDA?

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.

What is an establishment registration?

Establishment Registration. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Is FDA registration required?

FDA registration is required for all facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States by humans or animals. Companies located outside the United States must designate a U.S. Agent for FDA communications.