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FDA Is Cracking Down on Phony Registration Certificates

As protective equipment to combat and remain safe from the coronavirus surges, there has been a rise in unauthorized medical equipment and products. The FDA has now revealed its actions against businesses that market devices by falsely claiming approval, certification, permission, or oversight from the agency. Certain businesses may be using something called “FDA registration […]

NAFTA and the FDA

The North American Free Trade Agreement (NAFTA) assists with protecting the Food and Drug Administration (FDA) of the United States’ right to guarantee food safety and consistency within North America. Implemented on January 1, 1994, the agreement involves Canada, the United States, and Mexico and is meant to expand the scope of free trade and […]

Useful Information on FDA Certificate of Registration

Companies that manufacture goods subject to U.S. Food and Drug Administration (FDA) regulation are required to declare their facilities with the FDA. The FDA provides identification numbers upon active registration, but it stops short of providing Certificates of Registration. Even so, often purchasers or importers seek proof of their registration from vendors. UReg FDA Registrations […]

Common FDA Inspection Violations

Part of maintaining FDA compliance is ensuring that you’re taking all of the necessary precautions and steps to be compliant in the event of an FDA inspection. Where others have run into violation issues, you can avoid making these same mistakes by being aware of some of the most common violations and employing the steps […]