Centurion Draws FDA Warning Letter for Unapproved Devices

The FDA has issued a warning letter to Centurion Medical Products of Williamston, Mich., for marketing unapproved sterile “convenience kits” intended for a variety of vascular and other medical procedures.

The letter, based on FDA inspections of the company’s Williamston and Howell, Mich., facilities, forbids distribution of the kits until they receive the agency’s approval.

Other violations by the firm included the failure to establish procedures for corrective and preventive actions, the agency said.