The Food and Drug Administration issued a warning letter to Philips citing significant violations at three of its medical device facilities.
The inspections took place between January and March 2025 at Philips Ultrasound facilities in Bothell, Wash., and Reedsville, Pa., and at Philips Medical Systems Nederland B.V. in Eindhoven, Netherlands. The FDA concluded the sites failed to comply with good manufacturing practices required under 21 CFR Part 820, which governs quality system regulations for medical devices, according to a Sept. 9 letter addressed to Philips CEO Roy Jakobs.
The letter outlined deficiencies in complaint handling, supplier oversight, corrective and preventive action, design validation and product distribution. Notably, the agency identified 54 complaint investigations from 2022 to 2025 that missed target timelines, with 23 exceeding deadlines by more than 100 days. Philips was also found to have distributed seven refurbished transducers past their verified three-year useful life.
Additional violations included inadequate documentation of device malfunctions that may require Medical Device Reporting and failure to submit a required correction and removal report for a 2022 transducer-related communication. A separate correction related to its IntelliSpace Cardiovascular software was submitted more than three months late.
In a statement to Becker’s, Philips said it “continues its efforts to strengthen patient safety and quality across the company,” citing a multi-year program designed to enhance its quality systems and transform its patient safety culture. The company said the FDA conducted inspections of nine global facilities earlier this year, six of which led to no observations. The three inspections referenced in the warning letter — involving two U.S. ultrasound facilities and one Netherlands site — resulted in observations related to documentation, processes and procedures.
“Philips has worked hard to address these observations through our quality program and continues to do so,” the company said. “While the Warning Letter makes reference to a number of Philips products, in relation to process issues, the products continue to be manufactured and sold.” Philips added that it does not expect any material commercial impact from the warning.
The FDA said it could not determine whether Philips’ proposed corrective actions were adequate and will verify remediation during reinspections. Four product reports related to ISCV software malfunctions were also flagged as potentially MDR-reportable events, which Philips had not submitted by the time of the letter.
