The Food and Drug Administration released a warning letter yesterday it had sent ot Guidant Corporation restricting the ability of the company to win approval for some new medical products. The reason for the restriction stemmed from Guidant’s inability to fully respond to FDA concerns about manufacturing procedures at the company’s largest plant. The FDA cited a lack of proper controls, procedures, and methods to validate product improvements it was making. The warning letter dated December 22, raised eight specific deficiencies and threatened more severe penalties if Guidant didn’t properly fix the problems.
The FDA warning letter comes a week after documents were filed in a Texas lawsuit showed that Guidant officials had projected that some patients might die because of short circuits in one of the company’s implantable defibrillators. But the documents also suggest that the company did not deem the unit’s overall failure rate high enough to warrant public disclosure.