FDA sends `Warning Letter` to Straumann`s Biora

In the course of a routine inspection of Biora AB, Straumann`s oral regenerative product company in Sweden, in October 2006, a U.S. Food and Drug Administration (FDA) investigator made a number of observations predominantly concerning maintenance of quality system documentation and procedures associated with the company`s products. Biora has received a “warning letter“ from the FDA, which indicated that its “dental bone grafting materials“ are on import detention in the U.S., until the inspectional observations are resolved. No other countries apart from the U.S. are affected. The products concerned are: Straumann BoneCeramic, Emdogain, and PrefGel.

Leave a Reply

Your email address will not be published.