Formulations, Paraffin, All

What Is FDA Product Code KEO?

Formulations, Paraffin, All is FDA product code KEO, Class 1, 21 CFR 864.4010.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Package design/selection (2) and Packaging process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.