Interventional device developer Guidant of Indianapolis said it has received a warning letter from the FDA related to its inspection and Form 483 observations of the firm's cardiac rhythm management facility in St. Paul, MN, conducted in September this year.
Guidant said it has provided the FDA with monthly updates on its progress and has thus far completed 90% of the commitments that it made in its initial response.
According to Guidant, the FDA letter indicates that it will not grant requests for exportation certificates to foreign governments or approve premarket approval (PMA) applications for class III devices that relate to observations requiring additional action, until such action has been completed.
The company said it will promptly respond to the warning letter and believes that it can fully address the concerns of the FDA without a material impact to its business. The Form 483 observations and Guidant's initial response can be found on the company's Web site.
By AuntMinnie.com staff writers
December 27, 2005
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