Philips Ultrasound Devices Deemed Adulterated Over Manufacturing And Oversight Lapses

Core Insights - The U.S. FDA found that medical devices manufactured by Koninklijke Philips N.V. at its Bothell, Reedsville, and Nederland facilities were deemed "adulterated" due to non-compliance with Good Manufacturing Practice (GMP) standards [1][2] Group 1: Manufacturing and Compliance Issues - The FDA identified that Philips failed to adequately oversee its internal contractor, Global Complaint Handling Operations (GCHO), which is responsible for managing complaint reviews and Medical Device Reporting (MDR) [2] - GCHO was not properly evaluated or listed as an approved supplier, leading to delays and incomplete investigations of complaints [3] - There were lapses in Corrective and Preventive Action (CAPA) systems, with recurring product issues such as fluid ingress and articulation failures in transducers not being consistently addressed [3] Group 2: Specific Findings at Facilities - At the Nederland facility, inspectors found design-validation shortcomings in the IntelliSpace Cardiovascular (ISCV) software, including inadequate cybersecurity and safety risk assessments [4] - Philips failed to submit timely MDRs for ISCV software malfunctions that could impact patient diagnosis or treatment [4] Group 3: Regulatory Impact and Stock Performance - Although Philips has initiated corrective actions, the FDA deemed several responses inadequate, indicating that further verification through follow-up inspections will be necessary [5] - The findings add regulatory pressure on Philips, which is already dealing with the long-term effects of its respiratory device recall and ongoing scrutiny of its quality systems [5] - Following the news, PHG stock declined by 5.85%, trading at $27.20 [5]