FDA tags closing Philips plant in warning letter for mishandling adverse event reports

The FDA recently released a warning letter it sent to Royal Philips (NYSE:PHG) over issues it found with a Cleveland, Ohio-based plant the company plans to close, citing numerous mishandled adverse event reports and other reporting and quality control issues.
The report relates to an inspection of the facilities performed by the federal watchdog between July 17 and August 18 last year and includes a total of nine observed issues.
In its warning letter, the FDA said that Philips failed to appropriately address 3,623 complaints it received from between July 2016 and July 2017.
The federal watchdog said that all of the 3,623 complaints in question were marked with a low hazard/harm symptom code, but also labeled as having a high risk matrix severity level, indicating the potential for serious injury or potential death, according to the warning letter.
The FDA also said that 1,792 of the submitted reports should have been escalated and further investigated by the company.
“The remaining 1,831 complaints were closed with no further evaluation or investigation and no documentation explaining the reason no investigation was necessary,” the FDA wrote in its letter.
The majority of these complaints were related to table problems, the FDA said, though it continues that it did not analyze the data to identify whether further investigation was necessary.
The federal watchdog cited another three observations related to how it handles complaints, including complaint handling, ...

Source: Mass Device - March 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Regulatory/Compliance royalphilips Source Type: news