Interventional device developer Guidant said that the U.S. Food and Drug Administration has completed its inspection of the firm's St. Paul, MN-based cardiac rhythm management facilities.
The FDA provided the company with a form FDA-483, noting one inspection observation, according to the Indianapolis-based firm.
Guidant said it will provide the FDA with a thorough written response to the
single observation in early March this year and that it anticipates being ready
for a follow-up inspection by mid-2006.
By AuntMinnie.com staff writers
February 23, 2006
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