About a week later, Little Canada-based St. Jude confirmed that it had received a "Form 483" from regulators—a document that notifies companies of "objectionable conditions" observed during inspections. Some of the regulators' concerns related to St. Jude's risk analysis of the design process for its Durata brand of leads, which connect defibrillators to the heart. Regulators also said St. Jude failed to adhere to its own policies regarding the testing of its Durata products.