St. Jude Medical Likely to Face Tough Questions About FDA Warning Letter on Earnings Call

The FDA sent a warning letter to St. Jude Medical on Jan. 10 regarding its inadequate design validation process for the Durata ICD lead at the medical device company’s Sylmar, Calif. manufacturing plant. The warning letter was expected as the company’s CEO Dan Starks had already alerted analysts that FDA could take action.
MedCity News