UNITED STATES ATTORNEY ALICE H. MARTIN NORTHERN DISTRICT OF ALABAMA
	FOR IMMEDIATE RELEASE			CONTACT: JILL ELLIS
	OCTOBER 29, 2007			PHONE: (205) 244-2001
	www.usdoj.gov/usao/aln			FAX: (205) 244-2171

 BIRMINGHAM MAN SENTENCED FOR
VIOLATION OF FEDERAL FOOD DRUG AND COSMETIC ACT

            BIRMINGHAM, AL - JAMES K.LEE, 62, of Birmingham, Alabama, was sentenced today to two misdemeanor counts of violating the federal Food Drug and Cosmetic Act.

            Lee operates Advanced Medical Systems, Inc. which is in the business of selling durable medical equipment. In 2005, Lee directed the manufacture of a catheter and sold the catheter without obtaining FDA approval. 

            “Persons who sell medical devices must follow the regulations established by the Food and Drug Administration.  Fortunately, there were no patients harmed by those unapproved catheters,” stated U.S. Attorney Alice H. Martin. “Devices which have not been approved for sale potentially pose health risks for the general public.”

            In a plea agreement, Lee has agreed to pay a $2,000 fine, probations for one year, and to attend 24 hours of educational instruction. At the educational seminar, Lee has agreed to wear a yellow tee or golf shirt garment, bearing the inscription: “I WAS CONVICTED OF VIOLATING THE FDCA.”

            The investigation was conducted by Special Agent Martha Hughes of the Food and Drug Administration’s Office of Criminal Investigations. Assistant United States Attorney Lloyd Peeples is prosecuting this case on behalf of the U.S. Government.

# # #