Posted 24 November 2017
By Allyn R. Becker, PhD, Mark Lookabaugh
The US Food and Drug Administration (FDA) has begun a widely recognized campaign of intensified surveillance of foreign manufacturers of Active Pharmaceutical Ingredients (APIs) and finished drug products. Failure to comply with the regulatory requirements for good manufacturing practice can subject a foreign firm to an import alert, thereby cutting off access to commercial distribution in the US. This article provides an overview of the consequences of an import alert and the steps that may be required to have an alert lifted by FDA.