The QMN Weekly Bulletin

Firm May Face $2.2 Million in Fines for GMP Violations

April 11, 2008

Alleging that the company made significant good manufacturing practice violations, including shipping a recalled product, the FDA is seeking $2.2 million in fines against Advanced Bionics and its president.

Advanced Bionics shipped hearing aids that posed “a significant public health risk” and exposed patients to device failure and possibly further hearing loss, the FDA said last month.

The agency originally filed its complaint last November and amended it in March. The complaint will be heard before an administrative law judge at the FDA in a procedure similar to federal court proceedings, an FDA spokeswoman told MQN. The FDA can initiate an administrative proceeding to impose civil fines of up to $1.1 million for each individual or corporate entity.

Advanced Bionics shipped hearing aids illegally between January 2005 and July 2006, according to the complaint. Two hearing aids shipped and implanted after a March 2006 recall contained a component from an unapproved vendor, the FDA said.

The company — at the time a Boston Scientific subsidiary — had voluntarily recalled the devices because of the potential for moisture in the internal circuitry, which could cause device failure.