St. Jude Medical disclosed last night that in late September, the FDA commenced an inspection of the company's Sylmar, California facility, and, following such inspection, issued eleven observations on a Form 483. The company said it has sent its proposed redactions to the FDA, and the FDA will make an independent assessment of the Form 483 before releasing it. The company will provide written responses to the FDA no later than Nov. 7, detailing proposed corrective actions, and has initiated efforts and redirected resources to address the FDA’s observations. St. Jude said it is "important to note that none of the observations identified a specific issue regarding the clinical or field performance of any particular device" and that the facility will continue to manufacture cardiac rhythm management devices while the company works with the FDA to address these observations.
- Government Agencies