The FDA on March 3 released Form FDA-483, which the agency issues to companies at the conclusion of an inspection in which inspectors have observed conditions that could be violations of the Food, Drug, and Cosmetic Act, according to the FDA's website. The report concerns inspections that took place in July and August of 2017 at the company's manufacturing plant in Highland Heights, OH, which makes CT scanners and advanced molecular imaging systems such as SPECT and PET/CT systems.
In the report, the FDA advised Philips that it is "not adequately investigating complaints" about its products, and the agency took issue in a number of different ways with the way the company handled complaints. For example, the report noted that of the 133,845 complaints received from July 2016 to July 2017, 129,736 or 97% were closed based only on the hazard/harm matrix (HHM) severity code that was assigned to them and were not further investigated.
The FDA report also noted that there were 3,623 complaints that received a low HHM severity level, indicating that they had less than moderate or no risk of injury to patients but had a high risk matrix (RMM) severity level, which is reserved for complaints that could result in serious injury or death. Of these complaints, 1,792 should have been escalated and forwarded to a special complaint-handling unit for further investigation, according to the agency.
In addition, a series of particular complaints should have been escalated but were not, the FDA believed. Some 68% of the complaints were related to table problems, according to the report.
The Highland Heights facility has experienced issues with the FDA regarding quality control and complaint handling in the past. The company shut down manufacturing of CT scanners at the plant in 2015 and recalled six models of CT scanners in July of that year. Philips in February announced that it would be closing down manufacturing at the Highland Heights facility in the second half of 2018 and would build a new R&D center in the Cleveland area.
Philips has submitted a formal response to the FDA's observations and noted in a statement that, by definition, a Form FDA-483 report records observations made by inspectors and "does not constitute a final agency determination regarding regulatory compliance. What's more, the company had "a constructive meeting with the FDA" in late 2017.
Regarding the closure of the Highland Heights facility, the company stated that this was a "business-driven decision," and output of the plant makes up less than 3% of the company's global sales volume of diagnostic imaging equipment.
"Therefore, we decided to focus Cleveland on R&D and training," Philips noted. "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."
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