Drugs

Centurion Medical Products Kit Issues

FDA says Centurion Medical Products, Williamston, MI, manufactures and distributes sterile convenience kits that have not been approved or cleared by FDA. A just-released 6/11 Warning Letter says the agency’s 8/5-8/20/19 and 11/21-11/1/19 inspections at two Centurion sites determined that the kits contain two or more medical devices and at least one drug co-packaged together. Generally, the kits are intended for use during a variety of vascular and other procedures, FDA says.

Specific violations noted in the letter are:

failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
failing to establish and maintain procedures for implementing corrective and preventive actions; and
failing to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.

The company was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each corrective action and a timetable for completing the steps. FDA also offered to meet with Centurion to discuss the violations and any planned corrective actions.

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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