Regulatory Focus™ > News Articles > 3 > Philips Medical Systems Draws Lengthy FDA 483 Over Issues with Thousands of Complaints

Philips Medical Systems Draws Lengthy FDA 483 Over Issues with Thousands of Complaints

Posted 08 March 2018 | By Ana Mulero 

Philips Medical Systems Draws Lengthy FDA 483 Over Issues with Thousands of Complaints

A US Food and Drug Administration (FDA) site inspection at the Philips Medical Systems manufacturing facility in Cleveland revealed inadequate handling of thousands of customer complaints, as well as numerous other GMP nonconformities, some of which led to more than 20 different recalls.

Agency investigators – who visited the facility for about a month in July and August 2017 – found major issues with the handling of the 133,845 complaints the medical device manufacturer had received from July 2016 through July 2017. For example, there were 129,736 complaints (97%) that had been closed “based only on the assigned [hazard/harm] symptom code and not further investigated.”

This flawed complaint handling system was being used at the facility despite the discrepancy between the assigned symptom codes and high-risk matrix severity levels of potential serious injury or death in 3,623 complaints – 1,792 of which should have been escalated, according to an FDA Form 483. Out of the 104 complaints with a hazard/harm symptom code, only 49% “were actually escalated.”

“The remaining 1,831 complaints were closed with no further evaluation or investigation and no documentation explaining the reason no investigation was necessary,” including complaints that described tables on the firm’s BrightView SPECT imaging system that “continued to move after letting go of buttons,” or got stuck and stopped working, FDA investigators noted.

Out of this large batch of complaints, 68% were related to table problems, with several complainants reporting the same issues happening monthly, or two to three times each year. But the firm closed these without taking the necessary corrective actions or submitting adverse event reports to FDA.

The firm’s complaint handling procedures were found to be lacking in that they did not include a description of “how and when failure codes are entered during the complaint process,” which in turn resulted in 129,736 complaints missing these codes “used for data analysis and to determine if further actions are needed.” They were also unclear at the time of the inspection “on when a complaint requires investigation and what level of investigation is needed,” the investigators added.

A 2015 revision to work instructions led to the removal of nine hazard/harm symptom codes that should have been escalated as they described electric shock, falling parts, among other issues. Since November 2015, there were 4,275 complaints that were not escalated due to the removed codes.

Other nonconformities revealed during the inspection include three repeat observations from an FDA visit in January 2014 that relate the firm’s inadequate and/or incomplete procedures for implementing CAPA actions, as well as for conducting risk analyzes and controlling suppliers. For example, a CAPA that was opened to address “software anomaly escapes” was later closed without a root cause investigation.

“After remediation activities were implemented in [January 2015], you reported 23 recalls related to software defects,” FDA said in the 483. “From February 2014 to the present, you have reported to the FDA 30 recalls (all Class II) related to software defects and you concluded that the cause of these were due to “software design controls.”

A supplier on probation since 2015 was associated with at least four recalls from 2014 to May 2016.

Philips spokesperson Steve Klink told Focus the observations were “already communicated at several occasions” last year after the inspection. Still, the 483 was made available to the public this week as the agency publishes those of interest on its website in response to inquiries from stakeholders.
“Philips submitted its response to the inspectional findings for review by the FDA,” Klink said, adding that the firm continues to provide status reports to FDA on its progress addressing the issues.

The firm’s diagnostic imaging manufacturing operations in Cleveland – which “currently make up less than 3% of the total global diagnostic imaging sales volume, will fully cease in the second half of 2018,” according to Klink. "Philips now plans on investing in a new R&D facility in Cleveland.”

Philips Form 483

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.