The FDA published a warning letter it sent to Cardiac Designs over issues associated with the company’s lack of design validation and how it handles and analyzes complaints about its device.
The letter was sent after an FDA inspector visited the company’s Round Rock, Texas location in June.
The agency investigator noted a failure in the company’s design validation procedures, which they said is contracted out to a separate company. The federal watchdog said neither the contract company nor Cardiac Designs had established appropriate validation procedures.
Cardiac Designs was also hit on their handling of complaints, another task the company contracts out to a separate firm.
The FDA said that though the company contracts out the job, its policy does not mention how Cardiac Designs, who are responsible for handling complaints, will receive said complaints and conduct complaint review investigations.
The agency mentioned a total 1,147 complaints received by the contracted company that had not reviewed or evaluated by Cardiac Designs, only the contracted company.
The warning letter said that Cardiac Designs is not properly documenting complaints as well, citing 87 complaints between April 4 and June 15 that were undocumented and unanalyzed.
The FDA referenced a complaint received on December 16 last year in which the monitor failed to detect an abnormal heart condition that was not evaluated.
The agency said the company failed to follow corrective and preventive action procedures. The warning letter referenced a case in which Cardiac Designs did not follow their procedures in relation to a risk management error, and an issue with training for corrective and preventive action procedures.
The federal watchdog finally touched on the company’s failure to conform to medical device reporting standards. The agency mentioned technical issues with undefined terms in its standards, as well as how the information was submitted and handled.