Washington, D.C. – October 30, 2025 – The U.S. Food and Drug Administration (FDA) has issued a warning letter to Royal Philips NV, citing significant violations of quality system regulations at three of the company’s medical device manufacturing facilities. The letter, dated September 9, 2025, and publicly posted on the FDA’s website today, declares devices produced at these sites „adulterated“ under the Federal Food, Drug, and Cosmetic Act due to nonconformance with current good manufacturing practices (CGMP) outlined in 21 CFR Part 820. The violations could impact the safety and reliability of ultrasound systems and related medical software used in diagnostic and therapeutic procedures.
The warning follows inspections conducted earlier this year at Philips Ultrasound, LLC in Bothell, Washington (January 13–31, 2025); Philips Ultrasound, LLC in Reedsville, Pennsylvania (January 23–March 13, 2025); and Philips Medical Systems Nederland B.V. in Eindhoven, Netherlands (January 13–17, 2025). These facilities produce critical devices including the EPIQ Elite and EPIQ CVx ultrasound systems, ultrasound transducers such as the X5-1c, X11-4t, S7-3t, and 3D9-3v models, IntelliSpace Cardiovascular software, and eCareManager. These products are classified as medical devices under section 201(h) of the Act, intended for diagnosing diseases, treating conditions, or affecting bodily functions.
The FDA’s Center for Devices and Radiological Health (CDRH) identified multiple deficiencies in Philips‘ quality management system, particularly in supplier oversight, complaint handling, medical device reporting (MDR), and distribution controls. The agency reviewed responses from Philips quality heads—Roxanne Ramirez and Ondrea Bermudez for the U.S. sites, and Rohini Gadre for the Netherlands facility—dated between February and August 2025. While acknowledging some remedial actions, the FDA deemed several inadequate and requested further documentation, including verification of compliance and attachments to support retrospective reviews.
Key Violations Detailed
- Inadequate Supplier Controls (21 CFR 820.50)
At the Bothell facility, Philips outsources complaint handling and MDR activities to its internal contractor, the Philips Corporate Global Complaint Handling Operations (GCHO) team within Philips Quality Enterprise Services (QES). Despite a service level agreement (SLA) outlining GCHO’s responsibilities—such as complaint evaluation, investigation, regulatory reporting, and submission—the firm failed to implement or follow its own Manage Supplier Quality Procedure (16.2.18), which treats internal service providers as suppliers.
Specific lapses include:
- No documentation of GCHO’s evaluation for meeting quality requirements or defining control extent, including failure to verify accurate complaint files or risk assessments per step 5.6.1 of Complaint Handling Procedure 9037-0052. Reviewed metrics focused only on complaint volume and status, ignoring broader quality key performance indicators (KPIs).
- GCHO was not listed on Philips Ultrasound’s Approved Suppliers List.
- Absence of a documented agreement requiring GCHO to notify Philips of service changes that could affect device quality.
Philips has since added GCHO to the approved list and executed a notification agreement. However, the FDA seeks details on ongoing evaluations to confirm GCHO’s adherence to revised procedures.
- Deficient Complaint Handling Procedures (21 CFR 820.198)
Philips‘ processes for receiving, reviewing, and evaluating complaints by a designated unit were inconsistent across sites, lacking clear delineation of responsibilities between GCHO, Bothell, and Reedsville. The Quality Manual (QMS 0048, Section 8.2.2) designates Bothell as the complaint handling lead, but procedures like Work Instruction 16.2.8.2 and 9037-0052 do not specify roles for outsourced elements.
Examples from Bothell and Reedsville include:
- Incomplete Records: Complaint 3478631 (June 3, 2023, EPIQ CVX system rebooting during stress echo) noted a transducer failure but omitted retrieval attempts, despite later repair on August 10, 2023. Complaint 4145110 (December 5, 2023, X5-1c probe causing patient abrasion) confirmed the issue and replacement but lacked investigation records or evaluation upon return.
- Misclassification: Complaint 4957970 (July 12, 2024, X11-4t TEE probe failing during three patient exams) was closed as a „non-complaint“ despite alleging performance deficiencies, violating the definition in Manage Complaints Procedure 16.2.8.
- Timeliness Failures at Reedsville: A review of 2022–2025 investigations showed 54 missing target completion dates (critical: 5 days; high: 5–7 days; medium: 10–15 days; low: 30 days), with 23 exceeding targets by over 100 days; 32 involved MDRs.
- Inadequate MDR Evaluations at Bothell: Complaints like 3936653 (October 9, 2023, probe breaking during cleaning or exam), 3117374 (March 9, 2023, intermittent failure during open-heart surgery), and 1440358 (October 20, 2021, transducer head separation during exam) lacked complete reviews, use-condition documentation, or reportability assessments for potential death or serious injury risks.
At Nederland: - Procedure 16.2.8.1 inadequately defines „Potentially Reportable Events“ (PREs), omitting malfunctions likely to cause death or injury if recurring.
- Eleven complaints on IntelliSpace Cardiovascular software malfunctions (traced to coding issues) were not escalated to the Defect Management system per Document 2005000033 (April 2022), despite requiring investigation under 21 CFR 820.198(c).
Philips reports procedure revisions, updated records, and a retrospective review of 127 complaints, but the FDA requires clarification on site responsibilities and the missing „127 complaints_Obs3b.xlsx“ attachment. Reinspections will verify effectiveness.
- Distribution Control Shortcomings (21 CFR 820.160(a))
At Reedsville, procedures failed to prevent distribution or use of transducers beyond their verified three-year expected service life, as documented in the Expected Service Life of Ultrasound Transducers guideline. This affects models like the 3D9-3v endo-cavity probe and S7-3t TEE probe. Inspectors observed seven refurbished transducers distributed past this lifespan, with approximately (b)(4) such units in the field. No procedures ensured only approved devices were released or that purchase orders resolved ambiguities before distribution.
The FDA noted this risks device reliability during clinical use.
Additional Concerns and Philips‘ Response
The letter also references a related correction or removal (C&R) reporting delay: Philips reported action 2023-EI-EDI-003 (FDA RES# 96129, including March 12, 2024, customer letters and Field Change Order 83000217) on January 8, 2025—outside the 10-working-day window under 21 CFR 806. Philips‘ May 9, 2025, response includes a new FDA Correction or Removal Reportability Guideline to address this.
A Philips spokesperson stated the company is implementing a multi-year quality enhancement program to resolve historical issues. Of nine global FDA inspections in early 2025, three yielded observations on documentation, processes, and procedures. Philips emphasized commitment to patient safety and regulatory compliance.
Implications and Next Steps
This warning adds to Philips‘ regulatory challenges, following a 2024 letter on a China facility and ongoing scrutiny over recalled respiratory devices like CPAP machines, investigated by the Paris Prosecutor’s Office. Analysts view it as a setback to Philips‘ efforts to stabilize operations post-recall costs exceeding €1 billion.
The FDA demands prompt corrective actions, warning of potential import alerts, device seizures, or injunctions if unresolved. Philips must respond within 15 working days with a plan, including timelines and effectiveness checks. Reinspections are anticipated.
For full details, see the FDA’s warning letter at fda.gov. Coverage draws from FDA records and industry reports.
