Round Rock, Texas-based Cardiac Designs received an Aug. 7 warning letter for design validation failures, inadequate complaint handling procedures and CAPA failures for its mobile heart monitoring device.

The FDA cites Cardiac Designs for not conducting validation studies to ensure the device meets user needs under actual conditions. Specifically, the company did not have any records demonstrating ECG Check Application software was validated, despite design validation SOPs that required software validation be maintained in the design history file.

The company also failed to document and evaluate complaints. A complaint log showed 87 complaints between April 4, 2014 and June 15, 2015, but they were not documented on a customer complaint report form. In addition, there were no records showing the complaints were even reviewed to determine if an investigation was warranted, the warning letter says.

Cardiac Designs also did not follow its SOPs for corrective and preventive actions. For example, a CAPA was opened on Dec. 30, 2013, to address a finding that the device’s risk management report “incorrectly identified labeling as mitigation of risk.” The CAPA states that the risk management report would be updated, but there was no record that it was corrected.

Another CAPA was opened in October 2014 after a third-party audit identified CAPAs were not being fully documented, and the company committed to providing additional training. However, the FDA inspector found “no record of these verification activities.”

The warning letter says that Cardiac Designs failed to develop, maintain and implement medical device reporting procedures, and that the company did not have definitions for what was considered a “reportable event.”

Cardiac Designs did not respond to a request for comment.

The first crucial question devicemakers must answer is when a process must be validated. Order our report Process Validation: A Guide for Devicemakers, which will walk you through each point in the decision-making process, including how to determine if a product can be “fully verified,” and how FDA inspectors define that term.