CYBERONICS RECEIVES FDA WARNING LETTER
The FDA warned Cyberonics of manufacturing deficiencies at the Houston plant that makes its sole product, the VNS Therapy System - a device that stimulates the vagus nerve to reduce seizures.
The letter from the FDA said the company's initial response to issues involving manufacturing practices at its Houston operation had been insufficient. Cyberonics Chairman and CEO Robert Cummins declined to comment on specific details of the FDA letter but said the agency's complaints run the "full gamut," from quality and design to complaint-handling.
FDA regulators inspected the facilities between July 20 and Sept. 15, 2004, and found practices that did not conform with U.S. requirements. Cyberonics said it subsequently submitted three written responses to the agency.