Avacen Warned for Lack of Multiple Manufacturing Procedures

Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. The San Diego company had not established procedures for acceptance activities, including inspections, tests or other verification activities, and could not provide any such procedures to the FDA investigator during a July 24-25 inspection, according to the Oct. 23 letter recently posted online.
Devices & Diagnostics Letter