Since the end of 2011 the FDA has sent 11 warning letters to companies in seven different countries that were exporting drugs to the U.S. after having let their required registration and listing expire.
The warning letter recipients also failed to respond to letters FDA sent them last year notifying them that they were not registered or listed for imports into the U.S., according to nearly identical language in the warning letters.
“FDA has established an ongoing program to identify drug manufacturing firms that have not complied with registration and listing requirements and to notify such firms of their ostensible noncompliance,” the agency said. “FDA has issued warning letters to some of the firms that have not responded to this notification and are out of compliance with registration and listing requirements. These warning letters have targeted firms whose lack of compliance has the greatest potential impact on FDA's regulatory mission.”
FDA’s focus on compliance at foreign drug manufacturing facilities has been sharper since the tainted heparin scandal in 2008, and new provisions in the recently passed user fee legislation is designed to reduce the number of unregistered facilities -- particularly for generic drugs.
But that was before sequestration.