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# Multiple Violations Seen in Contec Medical Inspection
- URL: https://www.fdaweb.com/multiple-violations-seen-in-contec-medical-inspection/
- Published: 2025-10-29T12:00:00.000Z
- Updated: 2026-09-14T15:25:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160126

A 6/9-6/12 FDA inspection at Centec Medical Systems in Qinhuangdao, China, found Quality System Regulation and other violations in its production of several medical devices. A 10/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/contec-medical-systems-co-ltd-717941-10022025?ref=fdaweb.com) says the specific violations were:

- failure to adequately establish procedures for corrective and preventive action;
- failure to adequately establish and maintain procedures for validating the device design;
- failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
- failure to adequately maintain records at a location that is reasonably accessible to responsible officials of the manufacturer and to FDA employees.

The letter says the inspection also determined that Contec failed to include a copy of all communications regarding the correction or removal of a device in a Medical Device Reporting report.

FDA says it has taken steps to refuse entry of Contec devices into the U.S. due to the serious nature of the violations. The company was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.