The FDA has published a warning letter it sent to Philips concerning three manufacturing facilities that failed to meet required manufacturing standards upon inspection.

The communication concerns inspections in early 2025 of three facilities in Bothell, Washington; Reedsville, Pennsylvania; and the Netherlands. The facilities manufacture ultrasound equipment and software for heart imaging and telehealth.

According to the FDA, the violations involve systemic failures to comply with Quality System regulations under 21 CFR Part 820. Among the most serious findings were deficiencies in supplier oversight, complaint handling, device distribution, corrective and preventive actions (CAPA), and design validation.
At the Bothell facility, investigators found that the internal complaint handling unit, the Global Complaint Handling Operations (GCHO), had not been properly evaluated or listed as an approved supplier, raising concerns about how device complaints are triaged and investigated.(As part of "limited restructuring," the Bothell facility has also announced plans to lay off 33 employees at the end of the year. Production operators, warehouse operators and technicians will be affected by the cuts, according to GeekWire, which Philips says are “completely unrelated to any regulatory action.")

The Reedsville site was found to have distributed refurbished transducers beyond their verified three-year service life, with seven such units linked to adverse event reports. Investigators also noted that Reedsville staff did not initiate CAPAs when required and lacked data to analyze trends in product refurbishments.

The FDA identified similar lapses at the Netherlands site, including failure to adequately assess software updates in the IntelliSpace Cardiovascular system for safety risks. Additionally, both the Netherlands and Bothell facilities failed to report certain device corrections and removals to the FDA within the required 10-day time frame.

The products are "adulterated,” the agency wrote, referencing Section 501(h) of the Federal Food, Drug, and Cosmetic Act, “in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with current good manufacturing practice requirements.”

While Philips submitted multiple responses between February and August 2025 addressing FDA Form 483 observations, the agency deemed many of the corrective actions either incomplete or inadequately supported by documentation. In some cases, promised updates and attachments were not provided for FDA review.

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