Guidant Corp., Indianapolis, said it can address the Food and Drug Administration's remaining concerns about quality control at the company's plant in St. Paul, Minn., without a material impact on business. An FDA warning letter said the company had not addressed all the violations identified in an investigation ended Sept. 1, and the agency said it will not grant Guidant pre-market approval applications or requests for new export permits until the issues are resolved. It also threatened seizure, injunction or fines unless the company takes action. In a news release, Guidant said it had corrected 90% of the deficiencies cited by the FDA and will respond promptly to the warning letter. Meanwhile, Boston Scientific, which recently outbid Johnson & Johnson in an effort to purchase Guidant, said it still is pursuing the deal. Guidant last week said its December U.S. sales and market share for implantable defibrillators are expected to return to September levels. The company said product recalls had reduced its market share to 70% from 80%. Read the FDA letter.
Guidant says will it address FDA concerns
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