GUIDANT RESPONDS TO FDA'S QUALITY SYSTEM QUESTIONS
In a recent response to an FDA Form 483 citing deficiencies in the company's quality system (QS) approaches, Guidant argued that while it is taking these concerns seriously, it believes its QS methods are in compliance with the agency's requirements.
The FDA issued a report Sept. 1 arguing that there were numerous flaws in the company's QS for its cardiac rhythm operations. The agency argues that the company's procedures for conducting QS audits were not complete and that Guidant failed to take certain actions to correct and prevent the recurrence of quality problems.
But the company responded in a Sept. 15 letter that it "believe[s] that [its] Quality System is in substantial compliance with the Quality System Regulations." However, the company also pledged to fully review its QS procedures at all of its cardiac rhythm operation facilities with an eye toward making any necessary improvements.