Philips Healthcare is taking action to address FDA concerns about its Cleveland imaging center.
Philips Healthcare's computed tomography and nuclear medicine headquarters in suburban Cleveland received a warning letter from the U.S. Food & Drug Administration, primarily over quality control and record-keeping issues.
The FDA listed 15 specific violations uncovered during inspections of Philips's imaging center in Highland Heights, Ohio last year.
For example, the company failed to report device malfunctions that "would be likely to cause or contribute to a death or serious injury if the malfunction were to recur," according to the warning letter.
The company will send the FDA a written response by the end of the month that will report on actions it has implemented and will implement to address the issues cited in the warning letter, a Philips spokesman told the Wall Street Journal. The company also hired an independent consultant to conduct a certified audit of the imaging facility.
Other problems cited in the warning letter include failing to investigate the cause of nonconforming products and failing to establish a procedure for receiving and evaluating complaints, plus various issues with employee training.
Warning letters are considered by the FDA to be informal and advisory and don't necessarily indicate that the FDA intends to take any punitive action against recipients.
The Philips spokesman said the issues cited in the letter weren't holding up sales. "We continue to produce and ship scanners at this point," he said
Netherlands-based Royal Philips Electronics employs more than 1,000 people at the Cleveland-area imaging center.