Cyberonics Issued FDA Warning Letter

Houston-based Cyberonics has been warned by the FDA about the company’s insufficient responses to problems with its manufacturing practices.

Cyberonics, a maker of medical devices for the long-term treatment of epilepsy and other chronic neurological disorders, received the warning letter from the FDA on December 22. It stated the company’s nonconformities with the cGMP requirements of the Quality System Regulation (QSR) for medical devices as specified in 21 CFR Part 820.

The letter followed an inspection of its Houston manufacturing operations from July 20 through September 15 of last year.

Cyberonics submitted several written responses to the FDA and met with agency officials, but the efforts still failed to satisfy the agency.

Company officials said they were “disappointed” with the FDA’s warning letter and were expected to complete a response to the FDA’s report by a January 19 deadline. Cyberonics’ officials added that it also received a warning letter from the FDA after the last inspection of its facilities in January 2001.

“Today, just as it was in 2001, Cyberonics is firmly committed not only to the design and manufacture of high-quality products that satisfy our customers’ needs but also to the compliance with all regulations,” said Cyberonics CEO Robert P. Cummins.