Home » Design Control, CAPA Violations Bring Warning for Transonic
Design Control, CAPA Violations Bring Warning for Transonic
July 30, 2013
Transonic Systems, a maker of devices to measure cardiac output, has fielded an FDA warning letter for design control and other quality system violations. According to the June 19 letter, the Ithaca, N.Y., company may have manufactured or released some of its COstatus units before the final gate of its “phase and gate approval system.”
The GMP Letter
The GMP Letter
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