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# QS, MDR Issues at Royal Philips China Plant
- URL: https://www.fdaweb.com/qs-mdr-issues-at-royal-philips-china-plant/
- Published: 2024-04-23T12:00:00.000Z
- Updated: 2026-09-14T14:28:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156827

A 10/23-10/26/2023 FDA inspection at the Royal Philips facility in Suzhou, China, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of computed tomography and ultrasonography systems. A just-released 2/23 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-philips-676605-02232024?ref=fdaweb.com) says the firm’s products are adulterated due to this Quality System violation: failing to adequately define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results. The letter says the firm’s responses to the inspection observation were not adequate.

FDA also says the firm’s products are misbranded because Royal Philips failed to submit to FDA a written report of a correction or removal of a device initiated to reduce a health risk or to remedy a violation that may present a health risk. The firm’s responses to that observation also were not adequate, the agency said.

Royal Philips was told to respond with a list of specific steps it has taken to address the noted violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.