Devices

Quality System Violations at Germany’s Biotronik

A 3/7-3/10/16 FDA inspection at Biotronik SE & Co., Berlin, Germany, found Quality System Regulation violations in the firm’s manufacturing of Selectra percutaneous catheters, Galeo coronary guide wires, implantable pacemakers, and implantable cardioverter defibrillators. A just-released 9/1/16 Warning Letter says that specific violations included:

failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure;
· failing to evaluate and select potential suppliers, contractors, and consultants for their ability to meet specified requirements, including quality requirements;
failing to ensure that where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer establishes and maintains procedures to adequately control these environmental conditions;
failing to establish and maintain procedures to ensure that sampling methods are adequate for their intended use;
failing to report to FDA no later than 30 days after the day that the firm received or otherwise became aware of information from any source reasonably suggesting that a device the firm markets had malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
· failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.

Given the serious nature of the violations, the letter says, the agency is detaining without physical examination Biotronik’s devices that are being shipped into the U.S. The firm must correct the violations and be re-inspected before the items can be released from detention, it says.

Biotronik was told to respond with a list of steps it has taken to correct the violations and prevent their recurrence, along with documentation of each step and a timetable for completion.

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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