Updated to reflect that the FDA document was a Form 483, not a warning letter, and to include commentary from a Philips spokesperson.
The FDA recently released a Form 483 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 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 Form 483.
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, corrective and preventive actions and the risk analysis of complaints.
Product conformity issues, incoming product regulations, process control procedures, design change management procedures and written MDR procedure issues made up the last five points in the federal watchdog’s posting.
A spokesperson for Philips said that the company has submitted a formal response to the FDA and is in discussions resolving the observations from the form 483.
The company said that the FDA issues had no bearing on the plant closure, and that the closure of the cite was a business decision based on its “strategic roadmap to drive growth of our diagnostic imaging business.”
“The Cleveland diagnostic imaging manufacturing operations currently make up less than 3% of the total global diagnostic imaging sales volume. Therefore, we decided to focus Cleveland on R&D and training. We are convinced that with these investments and fine-tuning of our global footprint, we can take advantage of existing efficiencies to accelerate innovation, while further enhancing our customer services,” a Philips spokesperson said in an email to MassDevice.com
Philips originally announced the closing in February. The factory is used to make computed tomography scanners, and its closing came as part of a $600 million research and development initiative, according to Philips.