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# MDR Violations Found at Philosys Company
- URL: https://www.fdaweb.com/mdr-violations-found-at-philosys-company/
- Published: 2020-05-05T12:00:00.000Z
- Updated: 2026-09-14T16:13:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146717

An 8/27-8/30/19 FDA inspection at Philosys Co. Ltd., Gunsan-si, Korea, found Medical Device Reporting (MDR) Regulation violations in the firm’s manufacturing of self-monitoring blood glucose test systems. A just-released 1/14 Warning Letter says the inspection also revealed several “nonconformances” that were documented in an FDA-483\. Specific violations and nonconformances listed in the letter were: 

- failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, reasonably suggesting that a device that the firm markets may have caused or contributed to a death or serious injury;
- failing to maintain information in the firm’s possession or references to information related to the adverse event, including all documentation of the firm’s deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was not reportable under FDA regulations;
- failing to adequately establish procedures for changes to a process; and
- failing to submit initial and supplemental or follow-up reports to FDA in an electronic format that FDA can process, review, and archive.

FDA was unable to determine the adequacy of the firm’s responses to the MDR violations because Philosys did not provide documentation of planned corrections. The firm was told to respond with a list of specific steps taken to correct the violations and prevent their occurrence, with documentation of each step and a timetable for completing the steps.

FDA said it was not pursuing further regulatory action on the nonconformances and told the firm it should take prompt action to correct them.