Devices

QS Violations at Sorin German Facility

An 8/24-8/27/15 FDA inspection at the Sorin Group manufacturing facility in Munchen, Germany, identified Quality System Regulation and other violations in the firm’s manufacturing of Stockert Heater Cooler 3T thermal regulator devices. A 12/29/13 Warning Letter says that specific violations noted on an FDA-483 included:
failing to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving of design changes before their implementation; failing to validate, with a high degree of assurance and approved according to established procedures, a process where results cannot be fully verified by subsequent inspection and test; and failing to adequately develop, implement, and maintain written Medical Device Reporting procedures.

The letter also says the inspection revealed that the Heater Cooler 3T devices are adulterated because the firm does not have an approved PMA or IDE, and are misbranded because the firm did not notify FDA of its intent to introduce them into commercial distribution. Further, the devices also are misbranded because Sorin failed or refused to furnish material or information about any correction or removal of a device to remedy a violation caused by the device which may present a health risk.

FDA says that given the serious nature of the violations, it is taking steps to refuse entry of the Heater Cooler 3T devices into the U.S., through detention without physical examination, until the violations are corrected.

Sorin was told to respond with a list of specific steps it has taken to correct the violations, documentation of each step, and a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome