Guidant Warned By FDA

Guidant Warned By FDA

The US Food and Drug Administration has issued a rare warning letter to the embattled company Guidant, of St. Paul, Minnesota.  Guidant is the infamous maker of tens of thousands of defective heart implants that have caused several deaths and other serious health problems.

While the letter has not been published by the FDA it is expected to be posted to the agency’s website later this week.  The warning letter states that Guidant has so far failed to remedy all 15 of the FDA’s criticisms of the company in September.  Guidant had previously stated that it was in full compliance will all of the FDA’s concerns.

Part of the letter states that the FDA expects Guidant to fully comply with safety procedures and other measures to ensure that future products cannot cause the types of serious problems that Guidant’s main products have in the past.  

The company is facing several lawsuits because of failing to report several short circuits in its heart defibrillator products even though they had previously known about the problems.  The company faces a shaky buyout by drug giant Johnson & Johnson, who have recently been criticizing Guidant more publicly and trying to get a better deal from the acquisition.

Shares of Guidant slid downward on the news of the FDA’s letter and the company has stated that fourth quarter profits may decline as well, mainly from the bad press about its products.

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