The US Food and Drug Administration (FDA) has hit Philips with a warning letter after quality control shortcomings were uncovered at three of its medical device manufacturing sites.
Issued on 9 September, the letter prompted Philips鈥� stock on the Nasdaq to dip 5.5% to a $27.30 close on 28 October after it was made public. Philips has a market cap of $27.4bn.
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The FDA鈥檚 letter highlighted issues pertaining to 鈥渁dulteration鈥� following its inspection of Philips鈥� two ultrasound manufacturing sites in Bothell, Washington, and Reedsville, Pennsylvania, along with its medical systems manufacturing site in Eindhoven, the Netherlands.
Following site inspections conducted between January and March 2025, the FDA said the manufacture, packing, storage, or installation processes at each site were 鈥渘ot in conformity鈥� with the current good manufacturing practice (CGMP) requirements.
Quality control and complaints processing inadequacies
The extensive violations identified by the FDA include Philips鈥� failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
For instance, during the Bothell site inspection, FDA investigators observed that Philips鈥� Ultrasound unit outsources complaint handling and 吃瓜黑料网 Reporting (MDR) activities to its contractor, the Philips Corporate Global Complaint Handling Operations (GCHO) team. However, the agency said Philips did not have adequate documentation to support or demonstrate that they had evaluated GCHO on their ability to meet quality requirements, as required by regulation.
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By GlobalDataAt Reedsville, further complaints processing issues were identified. FDA inspectors found that Philips failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
The FDA鈥檚 review of investigations from 2022-2025 revealed that 54 investigations did not meet the target dates, with 23 of the total upwards of 100 days past their target dates.
Design control flaws
Design control process shortcomings were also identified at the three sites. The FDA noted that multiple new requirements were added to Philips鈥� IntelliSpace Cardiovascular (ISCV) v8; however, the Netherlands facility failed to include these new product requirements in the ISCV Product Safety Risk Management Matrix.
As with the quality control updates Philips made, the FDA again noted that in responding to its concerns, Philips responses fell short, since they do not include analyses or evaluations to demonstrate that the possible hazards associated with each new feature had been adequately considered.
Ongoing concerns with Philips鈥� quality and manufacturing protocols
The FDA has advised Philips to take prompt action to address all violations identified in its letter, stating that failure to adequately address the issues may result in the agency initiating regulatory action 鈥渨ithout further notice鈥�.
In his closing remarks, Matthew G Hillebrenner, deputy director at the office of product evaluation and quality within the Center for Devices and Radiological Health (CDRH) at the FDA, told Philips the violations highlighted within the letter may be symptomatic of 鈥渟erious problems in your firm鈥檚 manufacturing and quality management systems鈥�.
鈥淵our firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance,鈥� Hillebrenner said.
The FDA鈥檚 conclusions from its site investigations reflect an evident continuation with quality and manufacturing problems at Philips, at a time where the company has been trying to turn a corner.
In 2023, Philips set aside 鈧�575m ($669m) to cover litigation costs over the recall of its faulty ventilator devices, and outlaid $1.1bn in 2024 to settle a range of lawsuits relating to its faulty sleep apnoea devices.
Increased FDA oversight?
Having analysed warnings letters issued by the CDRH, Andrew Thompson, director of therapy research and analysis for medical devices at GlobalData noted that there has been a steady increase since 2021, suggesting “either more violations in the industry as a whole, or increased FDA oversight is happening.”
In Thompson’s view, the latter is most likely the case, with the FDA holding industry more to account in terms of violations.
“Key driving forces include heightened scrutiny of data integrity, more inspections (both on-site and remote), and a sharper regulatory focus on high-risk product categories and foreign testing labs,” Thompson said.
“For instance, the FDA took particular issues with irregularities at Philips’ Netherlands factory. However, at this time we will likely see an impact to oversight tenor, due to the impact of FDA cuts and/or the US government shutdown,” Thompson added.
Editor’s note: This article has been updated to include commentary from Dr Thompson.
