The U.S. Food and Drug Administration (FDA) has issued a warning letter to Philips following the discovery of multiple quality system and manufacturing deficiencies across three of its medical device production sites. The letter, addressed to Philips’ CEO, cited concerns over product quality, complaints handling, and design control procedures.

The FDA’s findings stem from inspections conducted between January and March 2025 at Philips’ ultrasound manufacturing facilities in Bothell, Washington, and Reedsville, Pennsylvania, as well as its medical systems site in Eindhoven, the Netherlands. According to the agency, the manufacturing, packing, storage, and installation operations at all three locations were “not in conformity” with current good manufacturing practice (CGMP) requirements.

Among the key issues raised were significant inadequacies in quality control and complaint handling. The FDA noted that Philips’ Ultrasound division outsources complaint management and Medical Device Reporting (MDR) functions to the Philips Corporate Global Complaint Handling Operations (GCHO) team but failed to provide sufficient documentation proving the contractor’s ability to meet regulatory standards. In addition, the Reedsville site was found to lack formalized procedures for receiving, reviewing, and evaluating customer complaints.

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days.

Further concerns were raised regarding Philips’ design control processes. Inspectors found that the Netherlands facility did not properly integrate new product requirements into the IntelliSpace Cardiovascular (ISCV) v8 Product Safety Risk Management Matrix, leaving potential safety risks insufficiently evaluated. The FDA concluded that Philips’ responses to these findings did not adequately demonstrate that identified hazards were properly analyzed or mitigated.

The agency urged Philips to take immediate corrective actions to resolve the violations and warned that failure to comply could lead to additional regulatory measures “without further notice.” In a statement, Matthew G. Hillebrenner, Deputy Director at the FDA’s Center for Devices and Radiological Health (CDRH), emphasized that the issues identified may indicate “serious problems in your firm’s manufacturing and quality management systems.”

This latest warning follows a series of quality and compliance challenges for Philips in recent years. The company previously allocated €575 million ($669 million) in 2023 to address litigation related to ventilator device recalls and paid $1.1 billion in 2024 to settle lawsuits concerning faulty sleep apnea devices.

Philips has stated that it remains committed to resolving the FDA’s concerns and strengthening its quality management systems to ensure the highest standards of safety and reliability across its product portfolio.