St. Jude Medical, Inc. STJ, a global medical device company, today
announced that it has been notified by the U.S. Food and Drug
Administration (FDA) that issues cited in the Plano, Texas, facility's warning
letter have been addressed.
“We're pleased to have resolved the concerns identified by the FDA at our
Plano manufacturing facility," said Daniel J. Starks, chairman, president and
chief executive officer at St. Jude Medical. “We take quality and compliance
seriously and are committed to meeting and exceeding patient, physician and
regulator expectations in these areas.”
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