Quality System and Other Issues in CardioQuip Inspection

An 8/19-9/17/21 FDA inspection at CardioQuip, College Station, TX, found Quality System Regulation and other issues in the firm’s manufacturing of a cardiac heater-cooler product in various configurations. A just-released 2/11 Warning Letter says the firm holds an 11/19/2010 510(k) clearance for the CardioQuip Modular Cooler-Heater Model MCH-1000 device. However, it says, the model has been significantly changed or modified in design, components, method of manufacture, or intended use in multiple ways without the submission of a new 510(k).

The letter says the devices are also adulterated because the company does not have an approved PMA or IDE for them.

It lists these Quality System violations that also adulterate the product: 

•          failing to establish and maintain adequate procedures to control the device design to ensure that specified design requirements are met;
•          failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to an established procedure;
•          failing to establish and maintain procedures for implementing corrective and preventive action; and
•          failing to maintain complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. 

FDA says the firm’s devices are misbranded because CardioQuip failed to submit a report to FDA no later than 30 days after it received or otherwise became aware of information, from any source, reasonably suggesting that a device that it markets has malfunctioned and that device or a similar one would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

The letter says the firm’s response to the inspection observations acknowledges a need for it to make improvements but did not contain enough detail or supporting records to show the corrective actions will be adequate to address any violations and did not show a planned timeframe to complete the corrections.

“We request that your firm immediately cease any activities that result in the misbranding or adulteration of the MCH devices, such as their commercial distribution as discussed above,” the agency says.

FDA also asks the company to provide a more comprehensive corrective action plan, including supporting records to show completion of the corrective actions, and timeframes for ongoing corrections.